'I don't think Guidant can be faulted for a design flaw they did not anticipate. The issue is, knowing such a defect exists, what do you do about it?'

The admission by Indianapolis-based Guidant Corp., first reported Tuesday by The New York Times, came about after a Minnesota college student died on a spring break bicycling trip in March.

The death of 21-year-old Joshua Oukrop, who had a genetic heart disease, is the only one known.

Guidant disclosed the flaw in its Ventak Prizm 2 Model 1861 to Oukrop's doctors and told them about 25 other cases in which the defibrillator had malfunctioned, the newspaper reported. It did not, however, issue an alert to physicians until it learned the newspaper was preparing a story on the defibrillator.

Company officials did not return calls seeking comment Tuesday from The Associated Press.

Dr. Douglas Zipes, a heart expert at the Indiana University School of Medicine, said Tuesday even though the risk associated with the malfunction was small, the potential consequences were severe.

"I don't think Guidant can be faulted for a design flaw they did not anticipate," said Zipes, who edits the journal that received the manuscript in which two doctors revealed the flaw. "The issue is, knowing such a defect exists, what do you do about it?"

The company is recommending that the unit not be replaced.

A statement posted Tuesday on Guidant's Web site said the unit "continues to exceed design expectations and ranks overall as one of the most reliable (defibrillator) products available."

Guidant had not seen a compelling reason to issue an alert to physicians because the malfunction rate was low and replacing the devices might pose greater patient risks, Dr. Joseph M. Smith, a Guidant executive, told the Times.

"We choose to extraordinarily communicate when we have a product that does not live up to our expectations," Smith said, adding issues that could improve patient outcomes would also warrant an alert to doctors. "In this case, neither condition was met."

Electrical malfunctions involving the model occurred in units produced during a two-year period before mid-2002, when the company fixed the flaw, the Times reported. The problem has not happened in any devices made since.

In February, Medtronic Inc. told doctors that the battery used in one of its defibrillators was draining too fast. No deaths or injuries have been associated with the Medtronic model.

Implanted defibrillators, such as the one Vice President Dick Cheney has, shock the heart back into a normal rhythm when it starts beating irregularly.

Zipes, who is a consultant with Medtronic, said he advised the company to go public with the battery problem even though the risk was small, and leave the decision on replacing the units to doctors and patients.

Zipes said he did not think Guidant had acted unethically. "They just bet the odds and it didn't work out."

Oukrop's father, Lee Oukrop, who has the same genetic heart disease, had the same defibrillator until last week, when he underwent a replacement procedure.

"Whoever made this decision at Guidant, I pray he doesn't have a son who this happens to," Lee Oukrop told the Times.

Guidant is one of the largest makers of medical devices, with $3.8 billion (€3 billion) in sales last year, almost half coming from implantable defibrillators.