Friday, June 17, 2011

Boston Scientific recalls stent systems

By Julie M. Donnelly, Boston Business Journal

Boston Scientific Corp. (NYSE: BSX) has recalled more than 500 stent systems in its second recall for a potentially life-threatening defect to be disclosed this week. The stent may fail to deploy or partially deploy, the company said. A partial deployment could injure vessel walls or necessitate emergency surgery.

Natick-based Boston Scientific said the affected products are Innova Over-the-Wire Self-Expanding stent systems, which are used to treat “symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery.”

The company sent an urgent medical device recall letter to its customers on May 13, 2011, according to the U.S. Food and Drug Administration, directing distributors to halt distribution and return unused products to Boston Scientific.

The company said stents that have already been implanted do not pose a risk because the issue occurs during delivery of the device.

This is Boston Scientific’s second Class 1 recall – the most serious type, which could cause injury or death – disclosed by the FDA this week. Earlier this week, the agency alerted the public to a recall of more than 100,000 heart catheters.

A list of affected serial numbers for the Innova stent system can be found here.