Guidant Recalls 50,000 Defibrillators

INDIANAPOLIS (AP) -- Thousands of heart patients must decide whether to have surgery to remove their defibrillators after a company recalled 50,000 of the implanted devices, which are supposed to shock the heart back into a normal rhythm.

Guidant Corp. said Friday it was advising physicians about the safety of several defibrillator models, including 28,900 that could develop a short circuit and another 21,000 that could malfunction due to a computer memory error.

At least two patients with defibrillators made by the Indianapolis-based company have died, and Guidant said its devices had failed at least 45 times.

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 people who recently received a defibrillator shock should consult their physicians.

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, Minneapolis-based Medtronic.

Candidates for defibrillators include those who have had a heart attack or who have had an episode of rapid heart beating or are at risk for that, experts said. The devices are implanted under the collarbone and one or more wires are threaded into the chambers of the heart.

The recall came less than a month after The New York Times reported that Guidant failed to alert physicians about a potential problem with the Ventak Prizm 2 DR model defibrillator, one of those included in the recall.

Patients with the Contak Renewal and Renewal 2 also are affected; all three models will be replaced at no charge because of the short-circuit problem. More than 20,000 of those models are used by Americans.

Also being recalled are the Ventak Prizm AVT; Vitality AVT; Renewal 3 AVT; and Renewal 4 AVT ICDs. The company said those models can be reprogrammed at a doctor's office without being removed to fix a potential computer memory error. Some 18,000 of those are used by U.S. patients.

Overall, the company said about 63,000 of the devices had been implanted, with nearly 50,000 still in use. Company spokeswoman Annette Ruzicka said the devices cost between $20,000 and $35,000.

Vanderbilt University Medical Center cardiologist Jeff Rottman said he was not surprised by the recall and expected to hear from concerned patients over the weekend.

''My view is these are extraordinarily complex and truly amazing technologically sophisticated devices,'' he said. ''That they have problems and failures isn't at all surprising. But their communication was poor.''

Dr. David M. Salerno, a cardiac electrophysiologist at the Chattanooga Heart Institute in Tennessee, said about 50 of his patients have the potentially faulty defibrillators.

''I don't think every patient with one of these should panic,'' Salerno said. ''There's no defibrillator out there that's infallible.''

FDA spokeswoman Julie Zawisza emphasized that the recall was voluntary.

''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.''

A lawyer representing a Pennsylvania man who sued Guidant on June 1 over the faulty defibrillators disagreed, saying Friday's recall supports the lawsuit's allegations.

His client, John Brennan, 74, claims the company is financially liable to all patients implanted with one of its heart defibrillators because it did not tell them the devices could short-circuit.

''This is a health products corporation who for three years sold ticking time bombs, knowing they were doing so,'' Indianapolis attorney Irwin Levin said.

Shares of Guidant fell $1.20, or 1.6 percent, to close at $72.46 in trading on the New York Stock Exchange, where they have traded in a 52-week range of $49.95 to $75.15.

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Associated Press Writer Jamie Stengle in Dallas contributed to this report.

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