Breaking News October 14, 2005

Guidant Corp. told U.S. regulators that it had received reports of six additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms.?The failures were in the Contak Renewal and Renewal 2 models, the Food and Drug Administration (FDA) said in an update posted October 13, 2005 on the agency's website. The two devices were among models included in warnings Guidant sent to doctors in June 2005, which the FDA classified July 1 as recalls.?The added reports of failures bring the total worldwide to 21, including three cases in which patients died, Daniel Schultz, the director of the FDA's Center for Devices and Radiological Health, said.

Guidant Corp. had previously recalled several models of its cardiac defibrillators due to defects in the devices and numerous reports of device failure and death. The defibrillator recall and its follow-up advisory combined affect approximately 74,900 devices worldwide. The implantable cardioverter defibrillators, or ICDs, are intended to sense irregular heart rhythms and to send an electrical pulse to the heart to shock it into beating properly.

The Guidant defibrillator defects include short-circuiting, problems with the magnetic switch, and computer memory problems. The defect that causes short circuiting of the device caused the sudden death in March 2005 of a 21-year-old college student. Following are details of the models of 50,000 defibrillator devices affected by the recall and the follow-up advisory on June 16, 2005:

On June 24, 2005 Guidant issued an advisory about additional defibrillator devices, including the following models:

Guidant claims that it discovered the short-circuiting defect in 2002 and changed the manufacturing of the devices that year to correct the defect. However, Guidant continued to sell the old defective devices without notifying doctors that improved ones were available. Defibrillators cost approximately $25,000 apiece. Guidant's 2004 defibrillator sales totaled $1.8 billion, signaling that, at least until 2005, Guidant may have been more motivated by profits than by patient safety.?Heart patients with a defibrillator who are unsure if their device is one of the malfunctioning models should contact their doctor as soon as possible to determine whether their model requires replacement, whether their device can be reprogrammed, or whether their device is not affected by the recently announced safety issues.