Recall of Guidant Defibrillator Heart Devices
January 2006
On June 17, 2005, Guidant Corporation announced a recall of Guidant defibrillator heart devices. This recall was based on reports of 45 equipment failures, including the deaths of two patients as a result of the device failures.
On June 24, 2005 Guidant extended the recall to include additional defective devices, including several pacemaker models. On September 22, 2005, more warnings were announced for two additional pacemakers, the Insignia and the Nexus, that could fail, resulting in sudden and intermittent or permanent loss of pacing. The current list of potentially defective Guidant devices is as follows:
- Ventak Prizm 2 DR (model 1861)
- Contak Renewal (model H135)
- Contak Renewal 2 (model H155)
- Contak Renewal 3
- Contak Renewal 4
- Ventak Prizm AVT
- Vitality AVT
- Renewal 3 AVT
- Renewal 4 AVT
- Renewal RF
- Insignia
- Nexus
As of July 1, 2005, the FDA has given the highest recall priorty to the 20,600 Guidant defibrillators in service. Guidant then warned doctors on July 18, 2005 that approximately 28,000 pacemakers were potentially dangerous and may need replacement.
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