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Guidant Recalls Certain Implantable Defibrillators

Source: U.S. Food and Drug Administration
Published: June 27, 2005

Food and Drug Administration announced a few weeks ago that it is notifying health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.

The defibrillators affected by this notification are:
- VENTAK PRIZM 2 DR, Model 1861, ICDs 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, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT ICDs (All series numbers)

The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm. The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event for a patient. There have been two deaths reported to FDA suspected to be associated with this malfunction.

At this time, the FDA is not recommending that individual patients who have one of the Guidant devices have it removed or replaced.

"This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient," the Agency said. "Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision."

In May, Guidant notified physicians about a failure involving deterioration in a wire insulator within the lead connector block that, in conjunction with other factors, results in a short to the backfill tube, resulting in the device's inability to deliver therapy. Guidant said there have been twenty-eight reports of this failure worldwide, including one death, in 26,000 devices built prior to an April 2002 change in the device. No failures have been observed in the devices built after the April 2002 change. Approximately 17,000 devices built before April 2002 remain in service, including approximately 13,900 in the United States.

Johnson & Johnson said it is working to acquire Guidant Corp. by third quarter 2005.

Read Full Story at U.S. Food and Drug Administration

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