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FDA ISSUES RECALL ON GUIDANT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
THE FOLLOWING ARE THE 11 DEVICES AFFECTED BY THE RECALL:
- PRIZM 2 DR, MODEL 1861
- manufactured on or before April 16, 2002
- CONTAK RENEWAL, MODEL H135
- manufactured on or before August 26, 2004
- CONTAK RENEWAL 2, MODEL H155
- manufactured on or before August 26,2004
- VENTAK PRIZM AVT
Guidant Corporation has recalled the above defibrillators because they can develop an internal short circuit without warning, resulting in failure to deliver a shock to the heart when needed.
The malfunction causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. At this time it is not possible to provide accurate estimates of the failure rate for these devices, but at least two deaths attributable to this failure mode have been reported.
Advice for Patients
- If you’re not sure which model ICD you have, ask your doctor for this information.
- If you have one of the affected models, contact your doctor promptly to discuss the best course of action.
- Be aware that there is no way that you can test your device at home and there may be no signal that your ICD has malfunctioned, so it is important that you keep your regular doctor appointments.
- If you feel an electrical shock from your device, contact your doctor as soon as possible.
- If you or others hear a “beeping” from your device, this may signal a malfunction. Immediately contact your doctor or go to the nearest emergency room.
If you or or a loved one has been injured by a defective guidant defibrillator you may be entitled to monetary compensation. Complete the form below for a free evaluation of your claim by an attorney. There is no cost or obligation for this service.
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