Artery-Opening Stents Recalled By Boston Scientific
Friday, August 15, 2008
As a result of a defect that might cause part of the devices to snap off during surgery, Boston Scientific Corp. announced a recall of some artery-opening stents. The mesh-metal tubes are used to prop opening arteries after they have been cleared of fatty plaque deposits.
On August 14, 2008, the FDA said the tip of the device used to place the stent could break off during implantation, potentially causing stroke or internal injury.
Boston Scientific (BSX) made doctors aware of the voluntary recall in a June 6 letter, according to the notice posted to the FDA's Web site. The company said the recall applies to more than 2,200 devices distributed to hospitals worldwide between June 2007 and May 2008.
"All U.S. hospitals have responded to Boston Scientific, and a significant number of the distributed devices have been returned," the company said in a statement.
The FDA approved NexStent in 2006 for patients with clogged neck arteries, which carry blood between the heart and the brain. The stent is threaded up to the neck with a catheter through a small incision made in the groin.
Since problems with the nickel-titanium tubes only occur during placement, Boston Scientific said patients who already have NexStent are not at risk.
The use of bare-metal stents has gradually declined since 2003, when manufacturers introduced drug-coated stents. Boston Scientific does not break out sales of NexStent, but its interventional cardiology division which includes several stents, contributed nearly 40% of company revenue last year.
Posted in Medical Devices