Guidant Device Recall

GUIDANT - Defective Defibrillator Models

Home: Guidant pacemaker and Medtronic pacemaker models are at risk of failure.

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Defective Defibrillators & Pamakers. Learn about Guidant & Medtronic


Which implant devices were recalled in June 2005?
  • Ventak Prizm 2 DR (Model 1861), prior to April 16, 2002
  • Contak Renewal (Model H135), prior to Aug. 26, 2004
  • Contak Renewal 2 (Model H155), prior to Aug. 26, 2004
  • Ventak Prizm AVT
  • Vitality AVT
  • Renewal 3 AVT
  • Renewal 4 AVT
  • ... and many more have been added to this list in subsequent recalls by Guidant!

Frequently Asked Questions

Which Guidant Pacemaker Models are at risk of failure and who should get a replacement?

 

Initally the recall by Guidant appeared to be limited to 7 defibrillator models. We have now learned that the problem goes even further: almost 50,000 defective units -- 28,900 with the electrical problem, another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). Deaths have occurred and something must be done. We already know of two reported failures resulting in death.

It is not a surprise that patients are worried because they depend on the electric shock from their defibrillator to restore a normal heart beat. Thus, the very heart device that patients rely on to save their life may cost them their life. Having surgery to replace these devices means risking infection and scar tissue. It also means that they have to undergo the time and expense of surgery as well. But that risk is nothing compared to the risk of sudden death, and thus many patients will be advised by their doctors that it is worth the risk of additional surgery. However, morbidity rates in these replacement surgeries have been reported to be between 2% and 7% -- not an insignificant number.

One of the Guidant devices in question is the Prizm 2. It is one of the seven models that Guidant initally announced on Friday, June 17, 2005, had flaws in their design/manufacture. Some of the Guidant pacemaker devices have memory problems. As mentioned above, oringially, Guidant advised that the memory problems can be fixed without removal, but that is no longer the case. So like the other defibrillators, they have a more serious problem.

Remember that there are many models at risk. Between Medtronic and Guidant, there are probably over 150,000 units. For Guidant alone, the number of units is estimated to be over 100,000 units. And that may not be a final number. The recall has been done in stages. That is, the news of which units are subject to recall has only been "trickling" out. Rather than disclosing all of the information up front, there has been a slow but steady addition of units to the list.

For example, on June 17, 2005, Guidant initiated a worldwide physician communication regarding some important safety information and corrective actions for flawed implantable cardiac defibrillator devices.

At that time, the device models in question include:

  • VENTAK PRIZM 2 DR (Model 1861) ICDs manufactured on or before April 16, 2002.
  • CONTAK RENEWAL (Model H135) and CONTAK RENEWAL 2 (Model H155) CRT-Ds manufactured on or before August 26, 2004.
  • VENTAK PRIZM AVT, VITALITY AVT, & RENEWAL 3 AVT and RENEWAL 4 AVT ICDs (All series numbers).
But, recently, the recall was expanded and also includes pacemakers. Patients with the following models should also find out if they require replacement: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Contak TR, Virtus Plus II, and Intelis II. Who knows what is next. As we learn of additional models, we will update this list. The list has grown to a total of 20, or so, recalled models

Guidant has classified these as model recalls. Guidant has advised the FDA of the recall. Guidant has taken this action in order to limit adverse events from the potential failure of these units. There is also concern by the company due to a variety of individual lawsuits class actions being brough against Guidant.

The models have been recalled due to Internal short circuits, Memory errors, and Magnetic switch defects. There are also three classes of people who may need to have a replacement. These are: (1) implants that have not failed, where the patients require replacement; (2) implants that have not failed and where the patient is not healthy enough to undergo surgery for replacement; and patients with implants that have failed and the failure has caused either an injury or in some cases, death.

As mentioned above, Medtronic models are also at risk and may need replacement. The problems with the Medtronic units are a premature battery depletion, causing short circuiting and failure of the device when an arrhythmic event occurs. There may be as many as 65,000 Medtronic defective devices subject to recall. Feel free to contact us, no obligation, if you have a Medtronic pacemaker and want to see if you have a lawsuit against Medtronic.

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First Name:
Last Name:
E-mail Address:
Phone: () - ext.
Address:
City:
State:
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Age:
Date of Birth:

What complications have you had from the Guidant defibrillator implant?
For What recommendations have your doctors made about removing this device?
For Please list any relevant Surgeons, Hospitals, and Cardiologists who are treating or have treated you with respect to the Guidant implant. (Please include city & state)
Implant Date: What was the date you received your implant?
If removed, what was the date of REMOVAL of your implant?
Which manufacturer's device has been implanted? (please check all that apply)
GUIDANT
MEDTRONIC defibrillators
Which device(s) have been implanted? (see ID Card for Model #) (please check all that apply)
Ventak Prizm 2 DR (Model 1861), prior to April 16, 2002
Contak Renewal (Model H135), prior to Aug. 26, 2004
Contak Renewal 2 (Model H155), prior to Aug. 26, 2004
Ventak Prizm AVT
Vitality AVT
Renewal 3 AVT
Renewal 4 AVT
Medtronic Concerto
Unknown or Other
Additional Guidant Recall Lawsuit Information: Please be specific and tell us about your experience with the Guidant Defibrillator. Also enter any questions or comments in this space.
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