FDA MedWatch

Boston Scientific NexStent Monorail-Class I Recall Because The Tip Of The Stent May Detach From The Delivery System During Carotid Artery Stenting Procedures

08/14/2008- Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#NexStent