Boston Scientific's Innova Self-Expanding Stent System Recalled


June 17, 2011
The U.S. Food and Drug Administration (FDA) and Boston Scientific issued a class I recall for Boston Scientific's Innova Over-the-Wire Self-Expanding Stent System, because of complaints of no or partial deployments.

The FDA said this type of failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. The Innova Stent System is intended for use in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA).

Boston Scientific sent an urgent medical device recall letter to customers that explained the issue, identified the affected products, required distributors to cease further distribution and use of the product, and requested the return of unused products to Boston Scientific.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.