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FDA Backs Boston Scientific’s Recall Of Heart Devices

Law360 (July 12, 2006, 12:00 AM EDT) -- The U.S. Food and Drug Administration has thrown its support to Boston Scientific Corp.’s recommendation that doctors examine patients with implanted cardiac pacemakers or defibrillators that may pose a risk of malfunctioning.

Following five device malfunction reports, Boston Scientific recalled almost 23,000 pacemakers and defibrillators in late June. The FDA, which met with the medical device company last week to discuss the device recall, advocated the company’s actions to recall devices that had not yet been implanted in patients, according to an agency statement Tuesday....
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