Guidant Defibrillators
On Friday June 17, 2005, Guidant Corporation voluntarily recalled nearly 50,000 of its cardiac defibrillators due to a potential for malfunctions that could result in death. Soon after, Guidant issued another recall for nearly 80 of it’s Pacemaker models for similar reasons.
On Tuesday July 19, 2005, Guidant began notifying patients of new safety concerns regarding certain defibrillator models that were manufactured between November 1997 and October 2000. A sealing component used in these devices has been known to degrade over time, allowing moisture into the pacemaker case. The company said that of the 63,000 devices that were originally implanted worldwide, nearly 50,000 may still be in use.
To date, there have been reports of hundreds of Guidant Defibrillator failures, causing at least seven deaths. What is so alarming is the fact that Guidant has gone on record to acknowledge that even with all of the reports of complications, they were still selling older units out of their inventory.
Implantable defibrillators are intended to sense an irregular heart rhythm and shock the heart back into correct beating. Damage to the device circuits may be to blame for the inability of the device to deliver the required shock when a patient needs it. The defect described above causes the defibrillator to short circuit and malfunction resulting in serious injury and possibly death.
The following Guidant Defibrillator models were recalled on June 17, 2005:
- Ventak 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
- Ventak Prizm AVT (Model 1900)
- Vitality AVT (Model A135, A155)
- AVT Renewal 4 AVT
The following Guidant Defibrillator models were recalled on June 24, 2005:
- Contak Renewal 3 (Models H170, H173, H175, H177, H179)
- Contak Renewal 4 (Models H190, H195, H197, H199)
- Contak Renewal 3 AVT (Models M150, M155, M157, M159)
- Contak Renewal 4 AVT (Models M170, M175, M177, M179)
- Renewal RF (Models H230, H235, H239)
Of the 50,000 devices that have been recalled, Guidant anticipates that almost 30,000 will have to be replaced worldwide. It is expected that the remaining 20,000 devices can be corrected by external reprogramming.
If you or a loved one have experienced any major side effects as a result of a defective Guidant Defibrillator, please call us at 1.800.966.4999 or fill out the form for immediate attention to your case.
