June 17, 2011 — The U.S. Food and Drug Administration (FDA) said Boston Scientific has issued a class I recall for its 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. Boston Scientific is advising customers to immediately discontinue use of any affected product and return all products to the company.
The recall includes 505 devices. It 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 (PPA).
Boston Scientific sent an urgent medical device recall letter to 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 products to Boston Scientific.
To contact Boston Scientific complaint call center, call 800.811.3211
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.
For more information: www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm259462.htm