Guidant says more older pacemakers at risk

CHICAGO (Reuters) - Guidant Corp., the object of a bidding war between Johnson & Johnson and Boston Scientific Corp., on Monday said it has identified another batch of older-model pacemakers that are at risk of malfunction.

Guidant said the U.S. Food and Drug Administration has told the company it may consider the information an expansion of the original Class I recall on the pacemaker models.

The device maker recommends that physicians reassess their patients due to the discovery of additional devices with the potential defect.

Guidant on July 18, 2005, 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, the Indianapolis-based company said 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 Jan. 9, 2006, and it estimated 16,000 of the affected devices remain implanted in patients worldwide.

"The overall number where there is actually a problem is still low, but more importantly, you've got, once again, a revelation that the problem is a little wider than first thought," said Keay Nakae, analyst with C.E. Unterberg Towbin.

(Additional reporting by Julie Steenhuysen)