More Guidant heart device failures reported – FDA
October 13, 2005
WASHINGTON (Reuters) – U.S. regulators said Thursday they
had received 21 reports of device failures, including three
deaths, linked to some Guidant Corp. implanted heart
defibrillators as of October 7.
The Food and Drug Administration said six of the cases had
been reported after the agency issued a public health advisory
on July 14. The problems occurred with Guidant’s Contak Renewal
and Renewal 2 devices.
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