In what the Food and Drug Administration has classified as a recall, Guidant Corp. cautioned physicians about safety problems in approximately 50,000 of its implantable defibrillators. Doctors and patients must now weigh the risks of the safety problems against those of having surgery.
The recalls affect several different devices, including about 26,000 Ventak Prizms manufactured before April 16, 2002 and 16,000 Contak Renewals manufactured before Aug. 26, 2004. Guidant said there have been 28 reports of the Ventak Prizm short-circuiting, including one death, and 15 reports of shorts in the Contak Renewal devices, including one death.
Approximately 13,900 Ventak Prizm and 6,700 Contak Renewals have been implanted in U.S. patients.