Rockville, MD - The US FDA and Boston Scientific announced a class 1 recall of the NexStent Monorail, NexStent Carotid Stent, and Monorail delivery system because the tip of the stent-delivery system may detach during the procedure.

"This could lead to increased procedure time, cause vessel-wall injury, stroke, and/or emergency surgery to remove the detached tip," the FDA recall notice states.

The recall is limited to systems manufactured between June 12, 2007 and May 2, 2008 and distributed between June 19, 2007 and May 5, 2008; it does not apply to stents that have already been implanted.

The recall was initiated June 6, 2008, when Boston Scientific issued a voluntary device recall letter describing the issue, identifying the affected product, requesting that its customers cease to use or distribute the product, providing direction on how to return recalled devices, and issuing a tracking form to be returned to the company. In a statement, the company notes that products affected by the recall were distributed worldwide, with the exception of Japan.

The stent and delivery system are used in conjunction with the FilterWire EZ Embolic Protection System and are indicated for treatment of patients at high risk for adverse events from carotid endarterectomy who require revascularization and meet specific criteria, the statement adds.

The company notes that the total number of devices affected by the recall is 2690, of which 2217 were distributed and 473 remained in the control of the company. "At this time, all affected US hospitals have responded to Boston Scientific, and a significant number of the distributed devices have been returned to the company," the statement adds. "The company is working with the US Food and Drug Administration and has notified officials in other countries of this recall."

The affected products include 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].