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Guidant Recall - The HCMA responds


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Lisa Salberg Find out more about Lisa Salberg
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  • Guidant Recall - The HCMA responds

    The HCMA is clear in its mission and this mission leaves us in an interesting and perplexing position at this time. We have been working to raise awareness of HCM and assisting those with the condition to get the appropriate level of care for their condition. As 1 in 500 people in the USA have HCM and an estimated 20-25% of them are at elevated risk for sudden cardiac death we need to help these people protect themselves by means of the use of ICD’s. Simply stated the HCMA advocates the use of this important therapy in the appropriate patient population. The HCM community has a great interested in all of the companies that manufacture and develop ICD therapies. Those with HCM and ICD’s know that we are trusting our lives to a manmade device that is susceptible to human error and potential failure. We are also trusting the manufactures to provide timely and accurate information regarding problems, concerns or failures of devices. The recent news of recalls from Guidant have brought up many concerns and worries within the HCM community. While Medtronic and St Jude have also had advisories and programming recalls neither have raised the ethical and moral questions that Guidant’s failure for timely discloser have.

    An important question that needs to be addressed is the manner in which the patients were notified of the advisory or recall. The HCMA firmly believe that it is the responsibility of the manufacturer to notify the doctors and patients directly while also advising the media. Many patients have only found out about the recall due to media coverage, which leaves them open to many questions and unnecessary apprehension and fear.

    In the case of the Guidant’s Prizm 2 models there is no excuse to have withheld information on potential flaws in the device, which we now know to be responsible for at least 2 deaths. I know as a patient I want all information about my device so the I can discuss it with my doctor and make the best choice for me, I know many within the HCM community share my feelings. If there is a problem with a device patients have a right to expect full and complete disclosure, anything less is criminal. Now that the problem has been exposed the remedy provided by the manufacture was offering a replacement device and a minimal amount of compensation for uncovered medical expenses. Within one week of this offer, Guidant has issued a second advisory and has asked doctors to stop using 5 other ICD’s, thus leaving the question what ICD should patients receive as a replacement? And who is going to pay for these replacements?

    The other question that must be asked is who is responsible for the financial aspect of these situations? The patient and or their insurance company have paid for the original surgery and have paid for the original device. Now the manufacture has found an error issued a recall and the question must be who is responsible for the costs associated.

    In the end what is important to know is the ICD therapy have saved the lives of thousands of people and will save many more. The questions of how to deal with the reality of flaws in manmade devices and how we a society will deal with them are yet to be determined. I can assure you that the HCMA will be part of finding the solutions to these complex problems.
    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
    Thank you Lisa.

    It is very validating to have the support of the HCMA and the investment of all that you do to help all members through very tough times in their lives. The time that you give, the knowledge you possess, and that you share, combined with all your investigatory work is trully appreciated.

    Dx @ 47 with HOCM & HF:11/00
    Guidant ICD:Mar.01, Recalled/replaced:6/05 w/ Medtronic device
    Lead failure,replaced 12/06.
    SF lead recall:07,extracted leads and new device 2012
    [email protected] Tufts, Boston:10/5/03; age 50. ( [email protected] 240 mmHg ++)
    Paroxysmal A-Fib: 06-07,2010 controlled w/sotalol dosing
    Genetic mutation 4/09, mother(d), brother, son, gene+
    Mother of 3, grandma of 3:Tim,27,Sarah,33w/6 y/o old Sophia, 5 y/o Jack, Laura 34, w/ 5 y/o old Benjamin


    • #3

      That just about covers it all and to tell you the truth even though Guidant says i have one of the latter ones it still scars me as to wonder if they are telling me the truth being they kept the problem from us for soooo long, Pam I'm so glad you got your replacement I know you are resting better now I just know i would feel better if they would replace it

      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


      • #4

        Lisa this was very well stated. The recovery from the cover up for Guidant I am afraid will be a very long road. The media here has a daily piece in the paper about Guidant, both local news section and the business section. To date not enough has been said about the good and the lives that devices have saved, Guidant or other.


        • #5
          Many thanks to Lisa and the HCMA. Alan is getting his replacement Thursday morning and we still don't have the issue of insurance coverage worked out - we have been denied twice - once before the official recall and once after.

          Also, were it not for Lisa and the HCMA, we would still not have been informed that Alan's device is one that is affected. We have still not been contacted by the doctor or the hospital that did the implant. I don't understand why not.

          Thank you Lisa for all the support you give us.



          • #6
            Alan and Ange, Best wishes - We'll be thinking of you and waiting for an update - Linda


            • #7

              I have looked everywhere to find the official list if recalled AICD's to no avail. I have an A135 model number. I was wondering if someone knew the list or where to find it? Thanks!
              HOCM, alcohol ablation, AICD, Heart failure


              • #8
                Taken from the Guidant website:
                (please note this is ONLY one of the many recalls from Guidant in the past month)
                This is the link http://www.guidant.com/patient/commu...n/avt_qa.shtml

                Questions and Answers For Patients
                VENTAK PRIZM® AVT Model 1900
                VITALITY® AVT Models A135, A155
                CONTAK RENEWAL® AVT Models M150, M155, M157, M159, M170, M175, M177, M179

                Download and print this document

                62 KB PDF format
                Why has Guidant been in the news?

                Recently there has been discussion in the news regarding Guidant's communication of safety information on the VENTAK PRIZM AVT (Model 1900), VITALITY AVT (Models A135, A155) and CONTAK RENEWAL AVT (Models M150, M155, M157, M159, M170, M175, M177, M179) implantable devices as well as two other communications on different Guidant devices.

                How do I know if I have one of these devices?

                Guidant designs and manufactures three types of cardiac rhythm devices: pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, and several models of each type.

                To determine the model number of your device, check your Guidant patient identification card or call 1-866-GUIDANT (1-866-484-3268) in the U.S.

                What should I do if I have one of these devices?

                If you have questions or concerns, discuss them with your doctor.

                Continue normal follow-up visits as described in your patient handbook or as recommended by your physician.

                What is the appropriate follow-up period for this device?

                Your patient handbook recommends regular device check-ups. Your physician will advise you of the appropriate follow-up period for your specific situation.

                If I have one of these devices, what is the likelihood that my device will fail?

                While the medical device industry cannot create a device that never fails, Guidant's family of implantable devices continues to demonstrate extremely high performance and reliability. Historical reliability data is available in the 2004 CRM Product Performance Report (PDF format, 661 KB).

                Will I know if my device has failed?

                Implantable devices generally cannot be evaluated at home. There are no indicators we can provide you to assess your device. If you have questions or concerns, discuss them with your doctor.

                If I have this device, should it be replaced?

                Only you and your doctor can make this decision. However, Guidant does not recommend device replacement because the risk of this malfunction occurring is extremely low. This device performs very reliably. We have recommended that your physician consider making a minor programming change to your device.

                Does the fact that my device is the subject of a "recall" mean that my device should be replaced?

                An ICD or CRT-D device being the subject of a "recall" does not necessarily mean that it should be removed and replaced. Some devices that are recalled can be appropriately managed through changes to device programming, increased monitoring, or other non-invasive methods. You should consult with your physician to determine the type of follow-up most appropriate for you. The small risks associated with replacing the device may still be much higher than the risk that your device will malfunction. The pros and cons of replacement should be discussed with your physician.

                For more information about what a device recall means, visit the Heart Rhythm Society website at http://www.hrspatients.org/patients/...ls/default.asp.

                How committed is Guidant to the quality of my device?

                We strive to create the safest, most reliable devices possible. The safety and well being of patients is foremost in our minds.

                Our employees are committed to the idea that each device they "touch" might eventually be implanted in a family member or friend, relied upon for extending or improving his or her quality of life. That, more than anything, helps Guidant employees maintain their steadfast dedication to quality.

                Where can I get more information about Guidant devices?

                More information is available by calling 1-866-GUIDANT (1-866-484-3268) in the U.S. or visiting www.guidant.com.
                Other links:
                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)


                • #9

                  So, yes mine was recalled, but, I found out that all I have to do is go in and have it reprogrammed. Will be in first thing Monday afternoon. I'll let everyone know what happens. Thanks for the information.
                  HOCM, alcohol ablation, AICD, Heart failure


                  • #10

                    Thanks for your information on the recall. I especially appreciate your remarks about the need for a clearing house of information, a better notification and system, and the need to address the cost of a replacement - whether from the original manufacturer or a different one. Those "consumer" questions MUST be addressed, especially as more and more implantable devices are used (Medtronic is testing an implantable device for obesity.).

                    Thanks again.


                    • #11
                      ICD recall

                      I am in the difficult situation that both my daughter and I have Guidant devices implanted. My device has not been recalled (not yet at least), but hers has. She is 24 years old, and no longer has medical insurance of any kind. I don't think the $2500 that Guidant is so generously offering is going to cover the replacement surgery. We are therefore looking into the possibility of a personal injury lawsuit. The problem here of course is that the firms that are pursuing these cases are taking 40%, which may put her back at square one in terms of replacement. Is HCMA providing advice on how to pursue situations like this? I am a professor of medicine and still don't know how to proceed, I can imagine how difficult this is for the average patient. Any feedback would be appreciated.

                      David Rose
                      UCSD Department of Medicine


                      • #12
                        That is so sad that you and your daughter have to deal with this dilemma. Please contact the HCMA office at the number listed at the bottom of the screen and check with Lisa. I know she is out of the office until later in the week. But, there may be some other alternatives and help that may be available to you.

                        Best of luck,


                        • #13

                          I wouldn't be too quick to assume that the $2500 from Guidant won't go a long way to covering the surgery. You/your daughter should ask the physician involved about costs and specifically discuss the situation with your daughter. I know that in most cases the "retail" prices are much different than what the hospitals and doctors actually have contracts for with the insurance companies. I know the hospital bill for my ICD implant, including the bi-ventricular ICD device and operating expenses but not surgeon's fees, was around $89,000. The insurance company had a contract with the hospital that paid them ~$6,900--quite a difference. If need be, perhaps Guidant can help out with obtaining the contract rate for the surgery?

                          Good luck,
                          Rob Thomas
                          --Living life on the edge .. of a continent!
                          Charter member: Tinman Club