Boston Scientific Recalls Neck Artery Stent Products

Boston Scientific Corp. has recalled devices used in procedures to unclog neck arteries from hospitals around the world due to issues with a stent delivery system.

The company enacted a voluntary recall on June 6 for all unexpired units of the NexStent Carotid Stent and the Monorail Delivery System, and the Food and Drug Administration reported the recall on its Web site Thursday. Nearly 2,700 devices are affected by the recall, although 473 of them remained within company control. Affected devices were distributed between June 19, 2007, and May 2 this year, Boston Scientific said.

The recall does not affect stents that have already been implanted, because the problem in question occurs when the devices are threaded into place.

‘The tip of the stent delivery system may detach from the delivery system during the procedure,’ the FDA said. ‘This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip.’

Stents are tiny scaffolds used to prop open arteries sporting potentially dangerous lumps of plaque. While heart stents are the most commonly known devices, and are a huge business for Boston Scientific, carotid stents are not as widely used. Boston Scientific does not specifically break out carotid-stent revenue.

Carotid arteries are the main blood supply conduits to the brain. The build-up of debris in these arteries can pose a risk for strokes.

According to Boston Scientific, all affected U.S. hospitals have responded to the company’s recall notification, and a significant number of distributed devices have been returned.

The company said it is working with the FDA and has notified officials in other countries of the recall. The products in question were not distributed in Japan.

SOURCE: Dow Jones Newswires