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  • guidant recall hits the news...

    40,000 implanted heart devices recalled

    By Bruce Japsen
    Tribune staff reporter
    Published June 18, 2005


    Guidant Corp. Friday issued a worldwide recall of more than 40,000 surgically implanted cardiac defibrillators because of potential electrical malfunctions in the devices.

    It's the second major defibrillator recall this year. A Medtronic Inc. recall in February has resulted in new surgeries for more than 11,000 Americans who need the device to shock their heart back into a normal rhythm once it starts beating irregularly.

    The Guidant recall, however, caused mass confusion Friday among patients and their doctors because the Indianapolis firm and its sales representatives had been assuring them as recently as this week that it was not recommending replacement.

    The U.S. Food and Drug Administration has been investigating increasing reports of internal short-circuits, resulting in failure to deliver a shock when needed. Guidant devices have failed at least 45 times and have been linked to at least two deaths, one as recently as May 30, the company said.

    The recall surprised many doctors in light of recent assurances from Guidant that the devices were safe.

    "This is the device that they [Guidant officials] have been telling us is OK," said Dr. Brad Knight, a cardiologist and director of electrophysiology at University of Chicago Hospitals. "We just sent a letter to patients that it was OK to not replace their devices, pending further notification."

    Guidant first came under fire this spring after reports that it failed to alert physicians about potential problems with the Ventak Prizm 2 DR Model 1861 defibrillator.

    Those failures prompted Guidant to redesign the device several years ago, but the company said it believed the originals were reliable. As of Friday, there had been 28 reports of failure, including one death in 26,000 devices built prior to the April 2002 redesign.

    Friday's recall was broadened to include more Guidant models: Contak Renewal Model H135 and Contak 2 Renewal 2 Model H155, both made on or before Aug. 26, 2004; and Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT.

    The FDA said patients might need surgery to replace the devices with a new or different defibrillator, but that decision would have to come on a case-by-case basis after consultation with doctors. Some devices might simply need testing, the FDA and Guidant said.

    "We do not know which patient will need it replaced," said Julie Zawisza, an FDA spokeswoman. "That's a clinical decision that must be made by a physician and his or her patients. The risk of device failure that has been reported up to this point is very low."

    Guidant said it would replace the devices, which can cost $25,000, at no charge if the patient and physician decide it is necessary. The firm did not say whether it would pay any of the surgical costs, which can run between $8,000 and $14,000 if performed on an outpatient basis.

    Guidant advised patients with the device to see their doctors at three-month intervals and said any patient who recently received a defibrillator shock should consult with his or her physician.

    Guidant Chief Executive Ronald Dollens said the company would work with doctors as they decided how to best treat their patients in relation to the recall involving what he called a "small subset of Guidant devices."

    Doctors said Friday they and patients will have to weigh whether the risk of another surgery outweighs the risk of potential device failure.

    For some patients, that's not an easy call.

    Chicago resident Robert Adler said his Ventak Prizm defibrillator was manufactured after April 2002, putting him, according to his doctor, in a "gray area."

    "This is supposed to be about a life-saving device," Adler said. "Even if they say it could be a one-in-a-million problem, who wants to be that one?"

    The 86-year-old Adler, who is a retired hospital administrator, said he doesn't trust Guidant after the assurances it made and is angry with the company.

    "I want to give them a kick in the behind," Adler said, calling Guidant's handling of the defibrillator problems "very clumsy and very irresponsible."
    Doctors are being cautious about alarming patients, many of whom are elderly, about the need for another surgery until they know more.

    Knight, Adler's doctor, said his thinking leads him to consider surgery the riskier option.

    "My interpretation is that the likelihood of failure is lower than the risk of a major complication from replacing the device, which can be up to 1 percent," he said. "It's a risk-benefit just like everything else in medicine. It's not an absolute."

    In the Medtronic recall, the risk was also deemed low, but so far 13,000 people worldwide have had surgeries to remove and replace devices. The Minneapolis firm expects even more surgeries related to the recall of 87,000 devices but will not say how many in what was described as a "rare" flaw involving rapid battery depletion in its Marquis models.
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

  • #2
    Guidant recalls 50,000 defibrillators
    2 deaths, 43 failures linked to flaws; voluntary move reveals problems were more widespread than previously reported

    Related articles
    • Worry now beats in thousands of hearts



    By Jeff Swiatek
    [email protected]


    Guidant Corp. admitted Friday that flaws in its heart defibrillators were more widespread than previously divulged and issued a recall for 50,000 of the devices.

    The recall, worked out with the Food and Drug Administration, affects units made as recently as last year and raises new questions about the future of Guidant's proposed acquisition by Johnson & Johnson.

    At least two patients have died -- one more than previously acknowledged by the company -- and the implantable device failed in 43 other patients because of the problems linked to the recall, the Indianapolis medical device maker said.

    Flaws in two of the defibrillator lines can lead them to short-circuit when they are supposed to deliver a life-saving shock.

    The FDA is continuing to look at the situation to determine whether Guidant properly disclosed the problems.

    The voluntary recall, which leaves it up to doctors whether to replace the devices, reveals problems more far-reaching than Guidant disclosed last month in a letter sent to U.S. doctors about a defect in its Ventak Prizm 2 defibrillators made before 2002.

    That problem caused one patient death, in March of this year, the company said last month.

    But Guidant's recall notice indicates the flaw persisted in another line of defibrillators, the Contak Renewal. A patient with a Contak defibrillator died May 30 because of the short-circuit problem, and 14 other Contak devices failed because of it, the company said. Guidant didn't disclose any information about the patient who died.

    "I am not in a position to comment further," Guidant spokesman Steven Tragash said.

    The recall includes:

    • 17,000 Prizm 2 units, including 13,900 in the United States.

    • 11,900 Contak Renewal devices built on or before Aug. 26, 2004, including 6,700 in the United States.

    • 21,000 Ventak Prizm AVT, Vitality AVT and Renewal AVT devices, including 18,000 in the United States.

    The AVT group of defibrillators, which have atrial therapy capabilities, may contain a flaw because of a software memory error, which so far has caused two device failures, Guidant said. Neither failure led to patient injury, the company said.

    Guidant is one of the world's three largest sellers of heart defibrillators and pacemakers, which help correct the heartbeats of patients with weak or erratically beating hearts.

    Its defibrillator and pacemaker business is based in St. Paul, Minn., where many of the devices also are made.

    Guidant President Ronald W. Dollens said in a statement: "We will work with physicians as they decide how best to treat their patients. Patient safety is paramount and our highest priority."

    Only a portion of the 50,000 patients with the recalled units will likely choose to replace them, which will limit the cost of the recall to Guidant, said Phil Nalbone, a medical technology analyst for RBC Capital Markets investment firm in San Francisco.

    The flaws in the devices are rare, amounting to well under 1 percent of units sold, Guidant said.

    The failure rate "is well under what we have come to expect from sophisticated devices of this nature," Nalbone said.

    He predicted the cost of the recall to Guidant would run in the tens of millions of dollars. That amount is "certainly nothing onerous, given Guidant's cash balances," he said. Guidant listed $1.5 billion cash on hand at the end of 2004.

    "This creates a lot of angst for patients and their families . . . but at the end of the day, I think it will be a very manageable financial issue for Guidant," Nalbone said.

    Guidant did not discuss the recall's potential cost.

    The recall notice comes after "intensive discussions" FDA officials have had with Guidant since learning about the Prizm 2 flaw last month, said FDA spokeswoman Julie Zawisza.

    During those discussions, the FDA started asking whether the Prizm 2 flaw might happen in other defibrillator lines, she said.

    "The answer was, 'Yes, it did,' " she said. During those discussions, Guidant told the FDA of a second patient death, she said.

    "We really felt we had to get that information out to the public" about the flaw in the Contak Renewal defibrillators, she said.

    She said "there's still a lot to be discussed and worked out" with Guidant, including "what the company reported (to the FDA), and when, and was that all done properly."

    Guidant has said it reported all device failure incidents to the FDA as required by law.

    Guidant has run afoul of FDA reporting regulations in the past.

    In June 2003, the device maker pleaded guilty in federal court to 10 felony charges involving hiding from the FDA thousands of reports of medical problems with an abdominal aortic graft product.

    The Justice Department fined Guidant $92 million for those violations and required the company to adhere to a "corporate integrity agreement" that included a code of conduct and a training program for employees in reporting device malfunctions to the FDA.

    The FDA's Zawisza said she didn't know whether Guidant has lived up to that integrity agreement.

    The Minneapolis Star Tribune newspaper reported Thursday that the U.S. Department of Health and Human Services is looking into whether Guidant adhered to the integrity agreement in handling the defibrillator problems.

    The British Medicines and Healthcare Products Regulatory Agency also "is making inquiries with Guidant about the . . . defibrillator problem and its significance to U.K. patients," agency spokesman Stephen Hallworth said in an e-mail.

    Hallworth said Guidant didn't notify the British regulatory agency of the redesign of the Prizm 2 in 2002 to correct the flaw, nor did the company tell the agency about failures that prompted the manufacturing changes.

    Johnson & Johnson reaffirmed on Friday its intention to close the $25 billion takeover of Guidant in the third quarter of this year. But the New Jersey health products giant added that "the events raised by Guidant are serious matters, and Johnson & Johnson is engaged in discussions with Guidant to help the company understand the issues."

    Nalbone, the industry analyst, said, "It does look as if Johnson & Johnson has been taken somewhat by surprise" by the recall. But "it is not a deal-breaker."

    Guidant's stock price fell $1.20 a share Friday to $72.46. Johnson & Johnson shares rose 26 cents to $66.56.
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

    Comment


    • #3
      Guidant shares fall 2.7% in late session

      By Scott Banerjee
      Last Updated: 6/17/2005 7:46:16 PM



      SAN FRANCISCO (MarketWatch) -- Shares of Guidant Corp. fell nearly 3% Friday evening after acquirer Johnson & Johnson sounded a serious note following the recall of Guidant defibrillators.

      Meanwhile, shares of technology bellwethers Microsoft Corp., Cisco Systems Inc. and Intel Corp. continued to trade Friday evening as investors digested another day of gains on Wall Street.

      The Nasdaq-100 After Hours Indicator, which tracks the evening action of the technology-heavy index's leading shares, was down 1.03 at 1,537.1.

      Shares of Guidant Corp. (GDT) fell nearly 3% to $70.50. Johnson & Johnson (JNJ) said that it continues to work toward closing its proposed acquisition of the company in the third quarter, following the recall of Guidant's defibrillators after reports of two deaths and 45 failures. See full story.

      Johnson & Johnson said the events reported by Guidant are "serious matters" and that it's engaged in discussions with Guidant to help it "understand the issues."

      Microsoft (MSFT) shares were flat at $25.04 as the volume leader on INET.

      Intel (INTC) shares even at $27.12 as the world's largest chipmaker ended the day flat.

      Shares of Cisco (CSCO) gained 1 cent to $19.54 as the networking equipment provider also ended the day flat.

      The Dow Jones Industrial Average (INDU) closed up 44.42 points to 10,663.07, while the technology-heavy Nasdaq Composite Index was up fractionally to 2,090.11.
      Knowledge is power ... Stay informed!
      YOU can make a difference - all you have to do is try!

      Dx age 12 current age 46 and counting!
      lost: 5 family members to HCM (SCD, Stroke, CHF)
      Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
      Therapy - ICD (implanted 97, 01, 04 and 11, medication
      Currently not obstructed
      Complications - unnecessary pacemaker and stroke (unrelated to each other)

      Comment


      • #4
        Guidant announces huge recall

        50,000 heart defibrillators include flaw, could fail

        By Ashley M. Heher

        Associated Press


        INDIANAPOLIS – Guidant Corp. said Friday it was recalling cardiac defibrillators implanted in nearly 50,000 people worldwide because of a flaw that could cause them to malfunction.

        At least two patients with the devices have died. The Indianapolis-based company said it was advising physicians about the safety of several defibrillator models, which have failed at least 45 times.

        The U.S. Food and Drug Administration advised patients to see their doctor and said it would not recommend whether individual patients with one of the recalled devices should have them removed and replaced. Guidant offered to replace some of the defibrillators but has not said that removal or replacement of any is necessary.

        Implantable defibrillators are intended to sense an irregular heart rhythm and shock the heart back into correct beating. The recall includes about 38,000 devices used by patients in the United States.

        “This is a voluntary recall,” U.S. Food and Drug Administration spokeswoman Julie Zawisza said. “We’re in complete agreement that they need to do that.”

        Guidant came under fire this spring after reports that it failed to alert physicians about potential problems with the Ventak Prizm 2 DR model defibrillator.

        Friday’s recall includes the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs. The company said about 63,000 of the devices had been implanted, with nearly 50,000 still in use.

        Guidant said patients implanted with those devices should continue to see their doctors at three-month intervals and any patient who recently received a defibrillator shock should consult with their physician.

        The company said a programming change can be performed for the Prizm AVT, Vitality AVT and Renewal AVT devices at a physician’s office to reduce the risk of a short circuit, while defective Prizm 2 DR and Contak Renewal devices will be replaced at no charge.

        “Patient safety is paramount and our highest priority,” Guidant CEO Ronald W. Dollens said in a statement. “Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcome and limit adverse events to patients.”

        This month, Guidant stood by its decision to continue selling the Prizm 2 DR for months after a potential flaw prompted a redesign, saying the original device was still reliable.

        In April, the company told doctors that the Prizm 2 DR defibrillator had failed in a small number of cases because of an electrical flaw. It also said that it had fixed the flaw in devices made after mid-2002.No failures in the Prizm 2 DR have been reported since April 2002. The faulty Contak Renewal defibrillators were manufactured on or before Aug. 26, 2004, Guidant said.

        A Pennsylvania man sued Guidant on June 1, claiming the company is financially liable to all patients implanted with one of its heart defibrillators because it did not tell them the devices could short-circuit. Lawyers for 74-year-old John Brennan said they hoped to make the legal complaint into a class-action lawsuit.

        Shares of Guidant fell $1.20, or 1.6 percent, to close at $72.46 in trading on the New York Stock Exchange, where they have traded in a 52-week range of $49.95 to $75.15.

        Guidant shareholders in April voted overwhelmingly in favor of a planned $25.4 billion acquisition by Johnson & Johnson. The merger, which still must win regulatory approval in the United States and Europe, would be the largest business deal in the 119-year history of J&J.

        J&J said Friday it continues to work toward completing the acquisition in the third-quarter, adding, “Nonetheless, the events reported by Guidant are serious matters, and Johnson & Johnson is engaged in discussions with Guidant to help the company understand the issues.”


        email this
        Knowledge is power ... Stay informed!
        YOU can make a difference - all you have to do is try!

        Dx age 12 current age 46 and counting!
        lost: 5 family members to HCM (SCD, Stroke, CHF)
        Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
        Therapy - ICD (implanted 97, 01, 04 and 11, medication
        Currently not obstructed
        Complications - unnecessary pacemaker and stroke (unrelated to each other)

        Comment


        • #5
          Well Lisa

          This puts a new light on things!!!!!! doesn't it I think i'm calling my doctor Monday or better yet i think i will bring the article to her and let her read it or him either one, i know if i had Dr. Maron he would have already made an appt for me to have it replaced, i think they are sitting on it here because mine has never shocked me and i've had a myectomy

          Shirley
          Diagnosed 2003
          Myectomy 2-23-2004
          Husband: Ken
          Son: John diagnosed 2004
          Daughter: Janet (free of HCM)

          Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9

          Comment


          • #6
            I am confused about the dates on the recall. I have a Ventak Prizm 1861 model implanted on September 11, 2002. Some articles seem to state the problem is in the models made prior to April of 2002 and others state the problem is in models made before November of 2002. Since I fall inbetween those dates, where do I stand? I have not been notified by my cardiologist, my EP (who implanted my device), or by Guidant. And how do I know that my device implanted in Sept of 2002 was not manufactured before April of 2002? Thanks, Vickie

            Comment


            • #7
              Shirley and Vicki,

              The serial number of your device (the number that is printed on the card that Guidant gave you) is the thing that you should go by. This is what is definitive. The dates will only give you an idea of whether yours might be in the recall.

              Guidant is required to keep a list of all serial numbers and will know which serial numbers fall into the recall. If they told Shirley that her serial number is not involved, then she is in the clear, regardless of the fact that her device model is the type that is involved in the recall. There are devices that are of the same model that are not involved in the recall that were manufactured after the problem was corrected.

              Your doctor will get a list of all serial numbers and will contact all patients eventually. It might take a couple of weeks, but they will notify you. You can either call Guidant or your doctor and ask if your serial number is involved, and if so, you and your doctor can decide what to do.

              I had my Medtronic replaced a couple of months ago due to the same type of issue, and it was not a big deal, although Medtronic was much more forthcoming with the information.

              Good luck.
              Daughter of Father with HCM
              Diagnosed with HCM 1999.
              Full term pregnancy - Son born 11/01
              ICD implanted 2/03; generator replaced 2/2005 and 2/2012
              Myectomy 8/11/06 - Joe Dearani - Mayo Clinic.

              Comment


              • #8
                Vickie, call your doctor. Guidant has also admitted to selling some of the flawed devices even after they made the manufacturing change. You can't be too careful.

                Reenie
                Reenie

                ****************
                Husband has HCM.
                3 kids - ages 23, 21, & 19. All presently clear of HCM.

                Comment


                • #9
                  Vicki,

                  My device was implanted in Nov 1, 2002 and it is one of the devices in question. I called guidant myself and gave them the serial number. They told me that if it was manufactured before Nov 1 than it probably is the one in question. So call them!

                  Mary S.

                  Comment


                  • #10
                    Someone mentioned that Guidant did not have anything on their website about this yet, but it is now there. I have a Vitality ATV and was very surprised to read here that it was also being recalled. Maybe I am naive, but when I read the writeup, the problem with my device sounds relatively minor. It sounds like they will temporarily turn off the atrial monitoring on my device to lower the probability of failure. I do have a question, however. They also discuss ending all ATP pacing as a way to further reduce the liklihood of failure.

                    I assume from what I read that this would not affect the fact that all my beats are paced. Is that correct? The way I understand my pacing is that my device picks up the signal from the atrium and passes it directly to the ventricle thus bypassing the confusing lesions along the way. In addition, if the atrial signal is not timely, the device generates its own signal for the ventricle. From what I read this will not be affected by the temporary changes in programming. Does anyone know if this is correct?

                    Thanks,
                    Rhoda

                    Comment


                    • #11
                      More HCMA members heard from.
                      Patients call doctors after Guidant recall

                      By ASHLEY M. HEHER
                      ASSOCIATED PRESS WRITER

                      INDIANAPOLIS -- Nervous patients called their doctors Monday to have potentially faulty implanted heart devices checked out after the company offered to replace thousands of them because of flaws.

                      For 44-year-old Alan Black, the potential for a short circuit in his defibrillator was enough to convince his doctor to schedule replacement surgery for June 30. The Lock Haven, Pa., resident got his device in 2002.

                      "It's really terrifying," said Black's wife, Angela. "This is something we've depended on and were told would save his life, but now we're not so sure. You've got to look at the risk of infection, the risk of scar tissue. But that risk was nothing compared to the risk of sudden death."

                      Black's device, the Prizm 2, is one of seven models the company announced on Friday had flaws. Some of the devices have memory problems and can be reprogrammed without removal. But nearly 29,000 of the defibrillators - 20,000 implanted in U.S. patients - can't be fixed externally.

                      Guidant said Friday it would pay for replacement of those defibrillators if patients' requested it. The announcement followed weeks of public criticism that the company had withheld safety information.



                      "I feel violated," said Pam Alexson, 52 of Rehoboth, Mass. The former nurse said she understood the devices weren't fail-safe, but the three-year delay in notifying doctors about malfunctions had destroyed her trust in Guidant. She's scheduled to have a model from a rival company implanted Tuesday.

                      An implantable defibrillator senses an irregular heart rhythm and shocks the heart back into correct beating pattern. The seven different models recalled by the company have malfunctioned at least 45 times, resulting in at least two deaths.

                      Stock analysts predicted the recall could cost Guidant up to $400 million. The Guidant devices cost between $20,000 to $35,000.

                      "Patients are appropriately nervous," said Kyle Kramer, executive director of the Yale-New Haven Health Heart Institute in Connecticut. "If there is a reported failure, or a reported flaw, you get a response of 'Oh my God.'"

                      Dr. Eric Prystowsky, an Indianapolis physician and a member of Guidant's medical advisory board, said patients who have defibrillators for preventive reasons might not need them replaced immediately. Others, who rely on electrical shocks from the devices several times a year, will be more likely to need replacement surgery.

                      Another consideration is the battery life of the defibrillator, since they need to be replaced every five to seven years anyway as their batteries run down. Patients with older models may opt to have their replacement surgery earlier than scheduled, he said.

                      "It's not a cookie-cutter approach," said Prystowsky.

                      Surgery to replace the defibrillators, which is implanted by making an incision near the left armpit, has a 1 percent chance of leading to a major infection, he said. "You have to weigh the risk/benefits."

                      Guidant officials on Friday encouraged patients to visit their doctors to decide the best course of treatment.

                      Guidant spokesman Steve Tragash urged patients to consult their physicians. "Guidant takes seriously its responsibility to physicians and patients to create the most reliable products and services, enhance patient outcomes and limit adverse events," he said in a statement Monday.

                      Design flaws in the defibrillators came to light after the March death of 21-year-old Joshua Oukrop, a Minnesota college student who died while mountain biking. His Prizm 2 defibrillator short-circuited and failed to work.

                      A patient with a different model, a Contak Renewal, died May 30.

                      Matthew Curtis, a lawyer who represents the Oukrop family, said the recall wasn't a surprise.

                      "It's a shame it took Joshua's death for Guidant to see the light," he said. "But thank God it might save people's lives in the future."

                      Guidant notified doctors this spring that a small number of the Prizm 2 defibrillators failed because of an electrical problem, which was fixed in mid-2002. Guidant shareholders in April approved a $25.4 billion acquisition by Johnson & Johnson. J&J said Friday it continues to work toward completing the acquisition in the third-quarter."

                      Shares of Guidant fell $2.16, or 2.98 percent Monday to $70.30 in trading on the New York Stock Exchange.
                      Knowledge is power ... Stay informed!
                      YOU can make a difference - all you have to do is try!

                      Dx age 12 current age 46 and counting!
                      lost: 5 family members to HCM (SCD, Stroke, CHF)
                      Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
                      Therapy - ICD (implanted 97, 01, 04 and 11, medication
                      Currently not obstructed
                      Complications - unnecessary pacemaker and stroke (unrelated to each other)

                      Comment


                      • #12
                        Recall pummels Guidant shares
                        Janet Moore, Star Tribune
                        June 21, 2005 GDT0621



                        Shares of Guidant Corp. continued their decline Monday after last week's recall of about 50,000 heart defibrillators that could malfunction in a small number of cases.

                        Guidant's stock closed Monday at $70.30, down $2.16. Since news of the recall hit Friday, shares have declined about 4.6 percent. Volume was heavy as about 9.7 million Guidant shares changed hands, compared with an average daily volume of about 2.1 million.

                        Wall Street is perhaps most interested in whether Johnson & Johnson's $25.4 billion acquisition, which is expected to be consummated in the third quarter, will move forward despite the recall.

                        Guidant has been dogged by controversy since May, when two doctors at Abbott Northwestern Hospital went public with concerns over quality control and disclosure procedures regarding one of its implantable defibrillators.

                        Most securities analysts seem to think the deal will move forward, but one downgraded the Indianapolis-based company's shares on Monday.

                        "The degree of reputational damage to Guidant's [implantable defibrillator] franchise, combined with potentially increased liability, may be great enough to induce [Johnson & Johnson] to seek reconsideration of its acquisition price," wrote Alexander Arrow of Lazard Capital Markets in a note to investors.

                        Arrow downgraded Guidant shares to "sell" from "hold."

                        Last month, Guidant acknowledged to doctors and patients for the first time that a model of its Ventak Prizm 2 implantable defibrillator made before April 2002 could short-circuit on rare occasions.

                        An implantable defibrillator, or ICD, is surgically inserted in a patient's chest and shocks their hearts if an erratic heartbeat is detected. Some 17,000 Prizm devices remain implanted in patients.

                        On Friday, the company widened its disclosure to include a recall of 11,900 additional devices from its Contak Renewal line of defibrillators. Guidant also said some of its ICD and cardiac resynchronization therapy devices with atrial therapy capabilities might be prone to a memory error.

                        Of the seven models recalled, 45 have failed, resulting in two deaths, according to Guidant. All of the devices in question are manufactured at Guidant's cardiac rhythm management division in Arden Hills and at a facility in Ireland.

                        However, Matthew Dodds of Citigroup/Smith Barney said in a note Monday that although the recall "represents another black eye," it "still does not look serious enough to warrant a breakup of the [Johnson & Johnson] deal."

                        On Friday, J&J issued a news release stating it was still working toward closing the deal in the third quarter. The New Jersey-based health care giant said it is "engaged in discussions" with Guidant regarding the ICD recall to help it "understand the issues."

                        J&J's stock closed Monday down a penny at $66.55.
                        Knowledge is power ... Stay informed!
                        YOU can make a difference - all you have to do is try!

                        Dx age 12 current age 46 and counting!
                        lost: 5 family members to HCM (SCD, Stroke, CHF)
                        Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
                        Therapy - ICD (implanted 97, 01, 04 and 11, medication
                        Currently not obstructed
                        Complications - unnecessary pacemaker and stroke (unrelated to each other)

                        Comment


                        • #13
                          San Francisco -- Thousands of nervous patients have been calling their doctors to get their implanted heart devices checked as the company announced a recall due to technical snags.

                          FDA on Friday announced that the company, Guidant has begun recalling about 50,000 faulty implantable defibrillators. It said it would pay for replacement of those defibrillators if patients demand.

                          Doctors say that outright replacement might not be a good idea as there’s a risk of infection when these devices are removed. So the decision whether to replace the device would be based on individual’s risk of having an arrhythmia in case of device failure and the risk involved in replacing the device.

                          There has been a lot of public criticism that the company withheld this information from the patients and the doctors.

                          The devices affected by this notification are:

                          # PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002

                          # CONTAK RENEWAL, Model H135, manufactured on or before Aug. 26, 2004

                          # CONTAK RENEWAL 2, Model H155, manufactured on or before Aug. 26, 2004

                          An implantable defibrillator senses an irregular heart rhythm and shocks the heart back into correct beating pattern.

                          Guidant spokesman Steve Tragash urged patients to consult their physicians. "Guidant takes seriously its responsibility to physicians and patients to create the most reliable products and services, enhance patient outcomes and limit adverse events," he said in a statement Monday.

                          Devices have been recalled after 45 device failures and two deaths have been reported.

                          The recall comes as health care giant Johnson & Johnson continues with plans to acquire Guidant, partly to gain access to its defibrillator line. The $25.4 billion deal was announced in December.
                          Knowledge is power ... Stay informed!
                          YOU can make a difference - all you have to do is try!

                          Dx age 12 current age 46 and counting!
                          lost: 5 family members to HCM (SCD, Stroke, CHF)
                          Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
                          Therapy - ICD (implanted 97, 01, 04 and 11, medication
                          Currently not obstructed
                          Complications - unnecessary pacemaker and stroke (unrelated to each other)

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