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.

Boston Scientific sent a letter to Innova customers outside of the U.S. May 13, according to the FDA, warning that it had received reports that the stent, used to treat lesions in the femoral artery and the adjacent proximal popliteal artery, failed to deploy completely or only partially deployed.

In late May, BSX said it was pulling all of the iCross catheters due to "embrittlement of the catheter material." The eight detachments the company confirmed in the U.S. and Puerto Rico happened between April 1 and May 10, according to the release."

The Innova recall does not affect stents that have already been implanted in patients. Here's a list of the lot or serial number of the 505 affected stents: