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Guidant warns of pacemaker problems

INDIANAPOLIS -- Guidant Corp. issued recalls or safety advisories for almost 170,000 of its top-selling pacemakers yesterday following a two-week federal inspection of its cardiac unit.

Since June, Indianapolis-based Guidant has recalled or issued warnings for about 88,000 heart defibrillators -- including its leading seller, the Contak Renewal 3 -- and almost 200,000 pacemakers because of reported malfunctions. Pacemakers use mild electrical current to speed a slow heartbeat; defibrillators use a bigger jolt to correct life-threatening irregular heartbeats. Surgery to remove and replace the devices is risky.

The latest advisory is the fifth in three months by the nation's second-largest cardiac-device maker and has renewed questions over its reporting of potential problems and a planned $25.4 billion acquisition by New Jersey-based Johnson & Johnson.

Some 80 percent of Guidant's heart products are now under recall or an advisory, according to an estimate by Jan Wald, an analyst with A.G. Edwards & Sons.

''It's gotten so that we keep waiting for the other shoe to drop," said Dr. Douglas Zipes, a heart expert at the Indiana University School of Medicine.

Johnson & Johnson stands by its August statement that it continues to work with Guidant on the impact of the recalls, spokesman Jeffrey Leebaw said. The company expects a decision on the merger by the Federal Trade Commission in October.

Guidant's disclosure yesterday, which focused on its top-selling Insignia and Nexus lines, affects about 56 percent of the company's pacemakers. The company urged patients to consult with their doctor but did not say the devices should be removed.

Failures in the devices has led to nine cases of emergency hospitalization, but no deaths, Guidant said.

A Food and Drug Administration report found that failures with the Insignia line were first reported in 2003 and occurred as recently as July.

As of September, users had not been informed of the potential for failure and the company continued to distribute the product, the report said.

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