FDA Recalls Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

Devices Used to Treat Carotid Artery Disease or CAD

Boston Scientific and the FDA have issued a Class 1 recall of stents used to treat blockages in people's carotid arteries. The specific stent models being recalled were manufactured from June 12, 2007 through May 2, 2008 and distributed from June 19, 2007 through May 5, 2008.

The stent model numbers are: Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300].

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 stent in the carotid artery to keep the artery open and to help prevent future narrowing of the artery.

The tip of the stent delivery system may detach from the delivery system during the procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip.

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Last updated on Sep-10-08