Guidant Corp. issued recalls or safety advisories for almost 170,000 of its top-selling pacemakers Thursday after a two-week federal inspection of its cardiac unit.
Since June, Indianapolis-based Guidant has recalled or issued warnings for about 88,000 implanted 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 about its reporting of potential problems and a planned $25.4-billion acquisition by Johnson & Johnson. About 80% of Guidant’s heart products are under recall or an advisory, according to an estimate by Jan Wald, an analyst at A.G. Edwards & Sons.
Johnson & Johnson stands by its August statement that it continues to work with Guidant to deal with the effect of the recall announcements, spokesman Jeffrey Leebaw said. The company expects a decision on the merger by the Federal Trade Commission in October.
Guidant’s announcement Thursday, which focused on its top-selling Insignia and Nexus lines, affects about 56% of the company’s pacemakers. It 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 Guidant continued to distribute the product, the report said.
The FDA classified Thursday’s recall as Class II, meaning that any injury caused by a malfunction should be temporary or pose a slight threat of a serious nature.
Guidant shares rose 86 cents to $70.35.