Guidant recalls 50,000 defibrillators

San Jose Mercury News ^ | Jeff Swiatek | Jeff Swiatek

[nickcarraway]

Guidant Corp. said Friday it was recalling cardiac defibrillators implanted in nearly 50,000 people worldwide because of a flaw that could cause it to malfunction.

At least two patients with the devices have died. The Indianapolis-based company said it was advising physicians about the safety of several defibrillator models, which have failed at least 45 times.

The U.S. Food and Drug Administration advised patients to see their doctor and said it would not recommend whether individual patients with one of the recalled devices should have them removed and replaced. Guidant offered to replace some of the defibrillators, but has not said that removal or replacement of any is necessary.

Implantable defibrillators are intended to sense an irregular heart rhythm and shock the heart back into correct beating.

The recall includes about 38,000 devices used by patients in the United States.

"This is a voluntary recall," U.S. Food and Drug Administration spokeswoman Julie Zawisza said. "We're in complete agreement that they need to do that."

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. The company said about 63,000 of the devices had been implanted, with nearly 50,000 still in use.

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.

[Run Silent Run Deep]

Shocking news!