FDA Investigates Boston Scientific Defibrillator Recall

Law360, New York (March 22, 2010, 4:57 PM EDT) -- The U.S. Food and Drug Administration has told physicians not to use two types of Boston Scientific Corp. heart defibrillators as the agency investigates the recently recalled medical devices.

The FDA said Friday that it was probing the Natick, Mass.-based company's recall of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Boston Scientific recalled the devices March 15 because it had failed to inform the FDA of manufacturing process changes. Companies are required to submit a notification of any change in manufacturing procedures or methods...
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