INDIANAPOLIS (AP) _ Guidant Corp. on Monday warned physicians that replacements might be needed for nine pacemaker models made between 1997 and 2000, of which some 28,000 remain implanted in patients worldwide.
The Indianapolis-based company, which last month recalled almost 109,000 defibrillators, released a warning that says a sealing component in the pacemakers has degraded in some cases, resulting in higher-than-normal moisture in the devices and possible malfunction.
About 78,000 of the pacemakers were distributed, with about 18,000 remaining in U.S. patients, the company said in the statement. The devices, which send electrical pulses to the heart to correct a slow heart beat, have a seven- to 10-year life span before they must be replaced.
Guidant said it has identified 69 failures among the pacemakers _ all after they had been used for at least 44 months. The models include: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR.
The company told physicians they should consider replacing the devices for patients who are dependent on the devices. Pacemakers are about the size of two half dollars held together.
Several patients implanted with the devices have lost consciousness or developed possible heart failure, Guidant said. It reported the death of one person whose pacemaker may have failed, but said the role of the device could not be confirmed as the device was not returned for testing.
Food and Drug Administration spokeswoman Julie Zawisza said the agency was evaluating Guidant's warning. Guidant said the FDA may classify the warning as a recall. The company issued two safety warnings last month for 11 models of defibrillators that were later classified by the FDA as recalls.
Defibrillators are also implanted devices; they shock the heart back into rhythm when it beats too quickly. Almost 88,000 of the Guidant devices that were recalled remain implanted worldwide.
Guidant's latest safety warning poses less of a health risk for patients than its defibrillator recalls, according to Dr. Angel Leon, chief of cardiology at Emory Crawford Long Hospital in Atlanta. He also said he expects more warnings to come from medical device manufacturers including Guidant as the companies respond to criticism that they've withheld safety information.
``What I tell patients is that every manufacturer of these devices has had failures, has had recalls and has had advisories,'' he said. ``It will continue to happen. It's how the companies handle the recalls that's important.''
Guidant said it would replace the pacemakers at no charge through the end of the year, even though the warranty on many has expired. The company will also reimburse patients up to $2,500 for medical expenses.
Guidant also said in its statement that it has planned to set up an ``independent panel of experts to recommend guidelines for when to disseminate information'' such as today's warning.
Shares of the company fell $1.11 to $68.30 in midday trading on the New York Stock Exchange; they have traded in a 52-week range of $49.95 to $75.15.
Guidant shareholders in April voted to accept an offer from Johnson & Johnson of $76 per share in cash and stock in a $24.5 billion deal that is still pending.
Jeffrey Leebaw, a spokesman for New Brunswick, N.J.-based Johnson & Johnson, said the company had no comment on Monday's warning. J&J said last month it was still working to close the acquisition in the third quarter but called the initial safety advisories ``serious matters.''
A.G. Edwards & Sons analyst Jan Wald said Guidant's newest warning follows continued internal scrutiny about potential malfunctions in its products.
``I think it's a company going through their files,'' he said. ``They've gone through their defibrillator product line. Now they're going through their pacemaker product line.''
Wald said he did not believe Monday's announcement would jeopardize the Johnson & Johnson deal. Guidant's second-quarter earnings are to be released Thursday.