FDA Seeks To Improve Safety Of Heart Defibrillators

Law360, New York (November 16, 2010, 12:02 PM EST) -- The U.S. Food and Drug Administration is calling for improvements in the design and manufacture of heart defibrillators after receiving more than 28,000 reports of safety problems with the devices over the past five years.

Both the number of medical device reports involving defibrillators — which include reports of patient deaths — and the number of recalls have climbed in recent years, prompting the FDA to take a closer look at the problem, the agency said Monday.

From 2005 to 2009, the number of safety reports...
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