Class 1 Recall: Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

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 product was manufactured from June 12, 2007 through May 2, 2008 and distributed from June 19, 2007 through May 5, 2008.

This device is used in patients to treat a blockage (stenosis) in the carotid artery, 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 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.

It is important to note that this recall does not affect stents that have already been implanted.

Boston Scientific Corporation issued a voluntary device recall letter on June 6, 2008 to their customers. The letter:

• described the issue
• identified the affected product
• requested its customers to cease using or distributing the product
• provided direction on how to return the recalled devices to the company.
• Included a tracking form to be returned to the company

Healthcare professionals and consumers may report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online : www.fda.gov/MedWatch/report.htm
• Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178