Guidant Finds More Older Pacemakers at Risk

Guidant, the object of a bidding war between Boston Scientific and Johnson & Johnson, announced that it has identified another batch of older-model pacemakers that are at risk of malfunction, according to Reuters news service. Guidant, the Indianapolis, IN-based medical device maker, said the FDA has told the company it may consider the information an expansion of the original Class I recall last July on the pacemaker models. In the original recall, Guidant told doctors about the potential for malfunction due to a problem with a sealing component used in certain pacemaker models manufactured between October 1997 and October 2000. Since then, it has identified a second group of devices, manufactured between October 1998 and December 2000, that could have the sealing problem. The company said there have been 145 incidents of malfunction related to the problem as of January 9, and it estimated 16,000 of the affected devices remain implanted in patients worldwide.