Health News

FDA: Some Guidant Defibrillators Recalled

June 17, 2005 -- The FDA says Guidant Corp. is recalling certain implantable defibrillators and cardiac resynchronization defibrillators.

"These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed," says an FDA news release.

The affected devices are:

• 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

The FDA says Guidant also recently informed the agency that it is recalling another set of defibrillator devices called Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance, says the FDA. The agency says it is evaluating that information.

Defibrillators 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 are designed to deliver an electrical shock to the heart to restore normal heart rhythm.

About 50,000 of the defibrillators remain in service worldwide, including about 38,000 in the U.S., says a Guidant news release.

Affected Devices' Problem

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 life-threatening event for a patient, says the FDA.

The FDA says it has gotten reports of two deaths suspected to be associated with this malfunction. One death was in a patient with a Ventak Prizm 2 DR device; the other was in a patient with a Contak Renewal device.

There have been 28 reports worldwide of the failure in the Ventak Prizm 2 DR device and 15 reports related to the Contak Renewal devices, says Guidant. Those numbers include the two deaths.

Guidant and the FDA both say patient safety is their top priority.

"We want to ensure that all patients who may be affected by this problem are notified and seek appropriate medical advice from their physicians," says Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health, in the FDA's news release

FDA's Advice

The FDA says it is not making a recommendation about whether individual patients who have one of the Guidant devices should have it removed and 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," says the FDA news release. "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."