Was the product recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure? Does the recall come as Boston Scientific is anticipating the lifting of its corporate warning letter? Will this action affect the approval of the firm’s next-generation drug-eluting stent?
IIP > read on here > http://www.fda.gov…
Class 1 Recall: Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System
Date Recall Initiated June 6, 2008 Product: 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. Use: 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. Recalling Firm: Boston Scientific Corporation 1 Scimed Place Maple Grove, Minnesota 55311-1565 Reason for Recall: 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. Public Contact: Patients with questions or concerns may call Boston Scientific Company at 1-763-494-1700.