Risk of Detached Tips Prompts FDA Recall of Boston Scientific NexStent Carotid System

On August 15, 2008, the U.S. Food and Drug Administration (FDA) announced a Class 1 Recall of Boston Scientific’s NexStent Monorail, NexStent Carotid Stent, and Monorail delivery system “because the tip of the stent-delivery system may detach during the procedure.”

According to the FDA recall, “This could lead to increased procedure time [and] cause vessel-wall injury, stroke, and/or emergency surgery to remove the detached tip.”

Specifically, the Class 1 Recall applies to “systems manufactured between June 12, 2007 and May 2, 2008 and distributed between June 19, 2007 and May 5, 2008” and does not apply to stents that implanted outside of these dates.

This device is used in patients to treat a blockage (referred to as stenosis) in the carotid artery, also known as carotid artery disease. The two carotid arteries (located on either side of the neck) supply blood to the brain. The device is used in a procedure called Carotid Artery Stenting (CAS), in which the physician places the self-expanding stents in the carotid artery to keep the artery open and to help prevent future narrowing of the artery.

Boston Scientific estimates that the “total number of devices affected by the recall is 2690, of which 2217 were distributed and 473 remained in the control of the company.” Furthermore, Boston Scientific has stated that it has contacted and provided notification of the above recall to “all affected US hospitals.”

If you or someone you know has suffered harmed or been injured as a result of a defective NexStent system, please contact our law firm for a free consultation.