Boston Scientific sent an urgent medical device recall letter to OUS customers on May 13, 2011. The recall notice explained the issue, identified the affected products, required distributors to cease further distribution and use of the product, and requested the return of unused product to Boston Scientific.
Reason for Recall: Complaints of no deployment and partial deployment have been received. This type of failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. This recall does not affect stents that have already been implanted as the issue occurs during delivery of the stent.
Use: 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.
Recalling Firm: Boston Scientific Corporation 1 Scimed Place Maple Grove, MN 55311
Public Contact: Boston Scientific Maple Grove Complaint Call Center: 1-800-811-3211. Or, Brent Hathcock, Field Action Team Lead at 763-494-7971.
FDA District: Minneapolis
Boston Scientific is advising customers to immediately discontinue use of any affected product and return all 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.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.