Boston Scientific Recalls Stent System Devices

Boston Scientific just issued a recall of over <"">505 Innova Over-the-Wire Self-Expanding Stent System devices, the U.S. Food and Drug Administration (FDA) just announced.

The complete list of recalled Innova Over-the-Wire Self-Expanding Stent System devices can be accessed on the FDA website.

The FDA said it classified this recall as a Class I, its most serious classification. Class 1 recalls involve situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.

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.

The recall was implemented following complaints of no deployment and partial deployment. 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.

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.

Boston Scientific Corporation is located at
1 Scimed Place
Maple Grove, Minnesota, 55311 and can be reached at the Boston Scientific Maple Grove Complaint Call Center, toll-free, at 1.800.811.3211, or by contacting its Field Action Team Lead, Brent Hathcock, at 1.763.494.7971.

Boston Scientific announced that it is advising customers to immediately discontinue use of any affected product and return all products to Boston Scientific.

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.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.