October 15, 2005
Guidant Reports Six More Defibrillator Failures
Posted at October 15, 2005 9:59 AM in Dangerous Products
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Guidant Corp. told U.S. regulators that it learned of six additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms.
The failures occurred in the Contak Renewal and Renewal 2 brand of devices, the Food and Drug Administration said. The two devices were among models included in warnings Guidant sent to doctors in June.
The new reports of failures since a previous FDA notice July 14 bring the total worldwide to 21, including three cases in which patients died, the FDA said.
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