FDA slaps Boston Scientific's recall of 500 Innova stents with Class I status

June 17, 2011 by MassDevice staff

Boston Scientific's recall of 500 of its Innova stents from overseas customers, after receiving complaints that the devices can fail to deploy or only partially deploy, is given the FDA's most serious Class I designation.

Boston Scientific

The FDA made a May recall by Boston Scientific Corp. (NYSE:BSX) of 500 of its Innova stents from customers overseas Class I, its most serious designation.

It's the second Class I recall for the Natick, Mass.-based medical device giant posted last month, after pulling all 30,000 of its iCross coronary catheters.

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