20 June, 2005 20:55 GMT
Thousands of cardiac patients must now consider surgery to replace possibly faulty implanted cardiac defibrillators after manufacturer
Guidant voluntarily recalled about 50,000 of the devices.
The recall, announced Friday, follows the deaths of two patients and at least 45 failures of the devices, the Indianapolis company said.
Guidant and the
Food and Drug Administration did not recommend that the devices be removed or replaced. Instead, Guidant and FDA officials said, patients should continue normal visits with doctors. Also, patients who recently received a defibrillation shock from their device should check with their doctors, Guidant said.
Risk of Failure Is 'Very, Very Rare'
Defibrillators are implanted in cardiac patients to sense and correct an irregular heartbeat. They are installed below the collarbone with wires running to the heart.
Guidant and the FDA said the recall involves:
About 29,000 devices that might develop a short circuit where they fail to deliver a shock when needed. These are the Ventak Prizm 2 DR and Contak Renewal models. Of these, about 20,600 are in use in the USA. Guidant said it would provide free replacements for patients seeking them.
Another 21,000 devices that could fail because of computer memory problems. These are the Ventak Prizm AVT, Vitality AVT and Renewal AVT devices. About 18,000 are implanted in the USA. For these, Guidant is recommending a programming change.
While some doctors expect Guidant patients to call and crowd waiting rooms today, they do not expect to replace devices in most patients. That's because the risk of failure is "very, very rare," and may be less than the risk of replacement, says Kenneth Ellenbogen, cardiac electrophysiologist at Virginia Commonwealth University School of Medicine.
'Serious Matters'
Most likely candidates for replacements are the minority of patients who also rely on the devices to keep their hearts beating, says Gregory Lewis of West Suburban Cardiologists in Chicago.
Jeffrey Olgin, cardiac electrophysiologist at the University of California, San Francisco, says he doesn't expect to recommend replacement for most of his patients, although he's still assessing the information.
The recall comes as health care giant Johnson & Johnson continues with plans to acquire Guidant, partly to gain access to its defibrillator line. The $25.4 billion deal was announced in December.
Friday, Johnson & Johnson said it "continues to work toward a third-quarter close" of the purchase. Still, it said the "events reported by Guidant are serious matters," and that Johnson & Johnson is attempting to better understand the situation.
Guidant shares closed Friday at $72.46, down $1.20.
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