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Guidant issues 2nd warning on defibrillators
Associated Press
Published June 25, 2005
INDIANAPOLIS -- Guidant Corp. on Friday issued its second safety advisory in a week about its implantable defibrillators, telling doctors to stop using five of the models because they could malfunction and may have to be recalled.
The announcement covered two devices that the company said last week could be repaired with reprogramming in a doctor's office: the Renewal 3 and the 4 AVT models. It also covers the Contak Renewal 3 and 4, and Renewal RF plans.
Last week, Guidant issued a worldwide recall of more than 40,000 surgically implanted cardiac defibrillators because of potential electrical malfunctions in the devices. Seven models were involved in that recall.
Shares of Guidant, the world's second-biggest maker of cardiac defibrillators, behind Medtronic Inc., sank more than 12 percent Friday before rallying to close at $63.90, down $4.70, or nearly 7 percent, on the New York Stock Exchange. It was their biggest drop in six months.
Guidant's recall last week was the second major defibrillator recall this year.
A Medtronic recall in February has resulted in new surgeries for more than 11,000 Americans who need the device to shock their hearts back into a normal rhythm once it starts beating irregularly.
About 46,000 of the $20,000 devices covered in Friday's announcement are in use worldwide, the company said. The Contak Renewal 3 is the company's largest seller, analysts said. Guidant reported $1.8 billion in defibrillator sales for 2004, an 18 percent increase from 2003 and 47 percent of the company's total sales.
Guidant said doctors "should discontinue implants of these devices pending further notice."
The company said that it had informed federal regulators of its action and that the Food and Drug Administration may classify it as another recall. FDA spokeswoman Julie Zawisza said the agency was evaluating the company's announcement and that it had not yet been classified as a recall.
"We support the company notifying the physician community and patients about this latest device issue," she said. "We'll be looking at the information they provided in the coming hours and days to evaluate the situation."
The five devices included in Friday's announcement have had at least four malfunctions among them, Guidant said.
A fifth suspected case has not been confirmed, but no patients using the devices have died or been injured, the company said.
Last week Guidant said two deaths had occurred in patients using the models included in its recall, without specifying the models. It also said the seven devices had had 45 failures among them.
An implantable defibrillator is intended to sense an irregular heart rhythm and shock the heart back into beating correctly. The device is the size of a small pager.
The five defibrillator models cited by Guidant Friday have a magnetic switch that can become stuck in a closed position, preventing the device from treating irregular heart rhythms. The faulty switch can also limit a defibrillator's battery life.
Guidant said physicians should reprogram the five defibrillator models so that their magnet use is off. The devices will continue to function. Patients who hear tones from the defibrillators, however, should go to the emergency room immediately.
"Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients," company spokesman Steve Tragash said in a statement. "The actions taken today and over the last several weeks reflect our commitment to expand physician and patient communication."
"The truth is if this is evidence of anything, it's that things are all upside down at Guidant," said Chris Seeger, a New York attorney who has filed a lawsuit against the company for what he says was its failure to notify patients about safety problems in defibrillator models.
Associated Press
Published June 25, 2005
INDIANAPOLIS -- Guidant Corp. on Friday issued its second safety advisory in a week about its implantable defibrillators, telling doctors to stop using five of the models because they could malfunction and may have to be recalled.
The announcement covered two devices that the company said last week could be repaired with reprogramming in a doctor's office: the Renewal 3 and the 4 AVT models. It also covers the Contak Renewal 3 and 4, and Renewal RF plans.
Last week, Guidant issued a worldwide recall of more than 40,000 surgically implanted cardiac defibrillators because of potential electrical malfunctions in the devices. Seven models were involved in that recall.
Shares of Guidant, the world's second-biggest maker of cardiac defibrillators, behind Medtronic Inc., sank more than 12 percent Friday before rallying to close at $63.90, down $4.70, or nearly 7 percent, on the New York Stock Exchange. It was their biggest drop in six months.
Guidant's recall last week was the second major defibrillator recall this year.
A Medtronic recall in February has resulted in new surgeries for more than 11,000 Americans who need the device to shock their hearts back into a normal rhythm once it starts beating irregularly.
About 46,000 of the $20,000 devices covered in Friday's announcement are in use worldwide, the company said. The Contak Renewal 3 is the company's largest seller, analysts said. Guidant reported $1.8 billion in defibrillator sales for 2004, an 18 percent increase from 2003 and 47 percent of the company's total sales.
Guidant said doctors "should discontinue implants of these devices pending further notice."
The company said that it had informed federal regulators of its action and that the Food and Drug Administration may classify it as another recall. FDA spokeswoman Julie Zawisza said the agency was evaluating the company's announcement and that it had not yet been classified as a recall.
"We support the company notifying the physician community and patients about this latest device issue," she said. "We'll be looking at the information they provided in the coming hours and days to evaluate the situation."
The five devices included in Friday's announcement have had at least four malfunctions among them, Guidant said.
A fifth suspected case has not been confirmed, but no patients using the devices have died or been injured, the company said.
Last week Guidant said two deaths had occurred in patients using the models included in its recall, without specifying the models. It also said the seven devices had had 45 failures among them.
An implantable defibrillator is intended to sense an irregular heart rhythm and shock the heart back into beating correctly. The device is the size of a small pager.
The five defibrillator models cited by Guidant Friday have a magnetic switch that can become stuck in a closed position, preventing the device from treating irregular heart rhythms. The faulty switch can also limit a defibrillator's battery life.
Guidant said physicians should reprogram the five defibrillator models so that their magnet use is off. The devices will continue to function. Patients who hear tones from the defibrillators, however, should go to the emergency room immediately.
"Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients," company spokesman Steve Tragash said in a statement. "The actions taken today and over the last several weeks reflect our commitment to expand physician and patient communication."
"The truth is if this is evidence of anything, it's that things are all upside down at Guidant," said Chris Seeger, a New York attorney who has filed a lawsuit against the company for what he says was its failure to notify patients about safety problems in defibrillator models.
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