NexStent, Monorail Recalled Because Tip of Delivery System May Detach During Procedure

 

August 14, 2008

August 14, 2008 - Boston Scientific and FDA today 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. Officials said the product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. The recall states this could lead to increased procedure time, cause vessel wall injury, stroke and possibly require emergency surgery to remove the detached tip.

The FDA said this recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions

For more information: www.fda.gov

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