Boston Scientific Recalls Innova SFA Stent System in International Markets

June 17, 2011—The US Food and Drug Administration (FDA) has posted notification of a Class I recall that was initiated on May 19 of certain lots of the Innova over-the-wire self-expanding stent system (Boston Scientific Corporation, Natick, MA) that were marketed outside of the United States.

The Innova stent system is intended for use in treating symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery. The Innova stent system received CE Mark approval in March, and the company began marketing the product in the European Union and other countries in the second quarter of 2011. In the United States, it is for investigational use only and is not available for sale.

The recall applies to 505 devices. The lot or serial numbers for those devices and contact information are posted on the FDA's Web site. The company is advising customers to immediately discontinue use of any affected products and return all products to Boston Scientific.

The company sent an urgent medical device recall letter to customers outside of the United States on May 13, 2011. The recall notice explained the issue, identified the affected products, required distributors to cease further distribution and use of the products, and requested the return of unused products to Boston Scientific.

According to the FDA, the reason for the recall was due to 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 because the issue occurs during delivery of the stent, the FDA noted.