FDA Recalls Guidant Defibrillators

The U.S. Food and Drug Administration will recall more than 38,000 faulty cardiac defibrillators implanted in patients because of potential malfunctions in the devices, the manufacturer Guidant Corp. said Friday.

Indianapolis-based Guidant said it was voluntarily advising physicians about the safety of several defibrillator models and that regulators had indicated the move would be classified as a recall.

The devices have failed at least 45 times and have caused at least two deaths as recently as May 30, the company said. Guidant came under fire this spring after reports that it failed to alert physicians about potential problems with the Ventak Prizm 2 DR model defibrillator.

Friday's recall includes the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.

CBS News Correspondent John Hartge reports that short circuits have caused the known failures. Some models have memory problems, which Guidant says can be fixed with reprogramming.

Guidant said patients implanted with those devices should continue to see their doctors at three-month intervals and any patient who recently received a defibrillator shock should consult with their physician.

"Patient safety is paramount and our highest priority," Guidant CEO Ronald W. Dollens said in a statement. "Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcome and limit adverse events to patients."

FDA officials did not immediately return messages.

Implanted defibrillators shock the heart back into a normal rhythm when it starts beating irregularly.

Earlier this month, Guidant stood by its decision to continue selling the Prizm 2 DR for months after a potential flaw prompted a redesign, saying the original device was still reliable.

In April, the company told doctors that the Prizm 2 DR defibrillator had failed in a small number of cases because of an electrical flaw. It also said that it had fixed the flaw in devices made after mid-2002.

Guidant shareholders in April voted overwhelmingly in favor of a planned $25.4 billion acquisition by Johnson & Johnson. The merger, which still must win regulatory approval in the United States and Europe, would be the largest business deal in the 119-year history of New Brunswick, N.J.-based health care products giant J&J. J&J has said it expects to complete the acquisition during the third quarter.

Johnson & Johnson did not immediately return a message.