FDA Calls Back Boston Scientific Stents, Catheters

Law360, New York (June 17, 2011, 6:08 PM EDT) -- The U.S. Food and Drug Administration on Thursday announced the Class 1 recall of Boston Scientific Corp. self-expanding stents, the second coronary device recall the company has faced in the past week.

The stent callback comes on top of the Class 1 recall of 110,020 Boston Scientific coronary imaging catheters on Tuesday over reports they could cause heart attacks.

An FDA statement said that more than 500 of Boston Scientific's Innova over-the-wire, self-expanding stent systems may not deploy fully, which could cause injury to the vessel...
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