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U.S. Department of Health and Human Services

Safety

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

Audience: Cardiologists, hospital risk managers

[Posted 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. 

[August 14, 2008 - Recall Notice - FDA]