Guidant Reports Six More Cases of Heart Device FailuresOct 14, 2005 | Star Tribune
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 models, the Food and Drug Administration said in an update posted Thursday on the agency's website. The two devices were among models included in warnings Guidant sent to doctors in June, which the FDA classified July 1 as recalls.
Guidant's cardiac rhythm management division is based in Arden Hills.
The new 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's June warnings affected 109,000 defibrillators and prompted the FDA and doctors to assess how to better notify doctors and consumers about risks of heart devices.
Guidant reported the additional cases to physicians and on its website last month.