Company: Defibrillators might be flawed

INDIANAPOLIS – A company under fire for not telling heart patients about a problem with its implanted defibrillators said Friday that 50,000 of the devices could be flawed and offered to replace more than half of them.

At least two patients with defibrillators made by Guidant Corp. have died, and the company said its devices had failed at least 45 times. Guidant said it was advising physicians about the safety of several models.

The Indianapolis-based company said, if requested, it would replace 28,900 of the implanted defibrillators that could develop a short circuit. More than 20,000 of those are used by Americans.

Another 21,000 devices – 18,000 used by U.S. patients – can be reprogrammed without being removed to fix a potential computer memory error, the company said.

The Food and Drug Administration advised patients to talk to their doctors and said it would not recommend whether individual patients with one of the recalled devices should have them removed and replaced. The company said anyone who recently received a defibrillator shock should consult his physician.

“This is a voluntary recall,” an FDA spokeswoman said. “We’re in complete agreement that they need to do that.”

An implantable defibrillator, smaller than a pack of cigarettes, is intended to sense an irregular heart rhythm and shock the heart back into correct beating. Vice President Dick Cheney has one made by another company.

Candidates for defibrillators include those who have had a heart attack or episode of rapid heart beating or are at risk of that, experts said. The devices are implanted under the collarbone.