Guidant Defibrillator

Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Implantable Cardiac Defibrillators

On June 24, 2005, Guidant said it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. At this time, Guidant is in the very early stages of a diligent evaluation of the component failure described below. Guidant will continue its evaluation and communicate further as more information is learned. As a precautionary measure, physicians should discontinue implants of these devices pending further notice. This communication advises physicians and their patients of safety information and is intended to limit adverse events. Physicians should use this information to decide how best to treat their patients.

The devices impacted are:

CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF

Guidant has determined that the devices listed above are subject to a component failure that may limit available therapy. They have determined that a magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device's ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion.

Guidant, the manufacturer of implantable defibrillators and cardiac resynchronization therapy defibrillators is recalling these devices because they can develop an internal short circuit without warning, resulting in failing to deliver a shock to the heart when needed.  Thus, failure could lead to a serious, life-threatening adverse event.

If you are a loved one have received a Guidant cardiac defibrillator please contact us for further information.

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