Guidant Defibrillators Get Highest Warning

The FDA is investigating how Guidant notified the agency and the public of the problem, said Timothy Ulatowski, FDA's medical device compliance chief."We are continuing to evaluate the circumstances surrounding the notification by Guidant," he said. The agency will announce its findings in "a matter of weeks, not months." Now listed as a Class 1 recall are three models: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.) The FDA said about 20,600 of these devices are still believed to be implanted; at least two patients have died.

Guidant Defibrillators Get Highest Warning - Yahoo! News

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