ISSUE: 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.
BACKGROUND: 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.
RECOMMENDATION: 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. See the Recall Notice for a complete list of affected lot numbers.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/17/2011 - Recall Notice - FDA]