Boston Scientific Recalls NexStents for Defect

Chrissie Cole
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Posted by Chrissie ColeAugust 14, 2008 12:17 PM

Boston Scientific announced a Class I recall of about 2,200 NextStents due to a defect that can cause part of the devices to break off during surgery.

The devices are used in patients to treat blockage in the carotid artery, known as carotid artery disease. The device is specifically used in a procedure called carotid artery stenting (CAS), in which the physician places the self expanding stent into the artery to keep it open and to help prevent future narrowing of the artery.

The following NexStents distributed worldwide to hospitals between Jun2007 and May 2008 are included in the recall:

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]

Please Note: this recall does not involve NexStents that have already been implanted.

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