Guidant Corp. advised doctors about safety problems with a subset of nine types of pacemakers manufactured between Nov. 25, 1997, and Oct. 26, 2000. The Food and Drug Administration could classify the action as a recall, the company said.
A sealing component used in some of the devices can gradually degrade, resulting in a high moisture content in the pacemaker case late in the device's service life, Guidant said. The company said it identified 69 devices that may have exhibited the problem from approximately 78,000 that were distributed. About 28,000 of those devices remain implanted worldwide.
Guidant recommended that physicians consider replacing the devices in pacemaker-dependent patients and consider other replacements on a case-by-case basis. Prompted by safety problems with its implantable cardioverter defibrillators, Guidant recently said it would establish an independent panel of experts to recommend guidelines on when to disseminate information regarding safety problems.