WASHINGTON (AP) -- Medical device maker Boston Scientific Corp. has recalled some of its artery-opening stents due to a defect that can cause part of the devices to break off during surgery.
The Food and Drug Administration said Thursday the recall affects the company's NexStent products manufactured between June 2007 and May 2008.
The mesh-metal tubes are used to prop opening arteries after they have been cleared of fatty plaque deposits. However, the FDA said the tip of the device used to place the stent can break off during implantation, potentially causing stroke or internal injury.
Boston Scientific alerted doctors to the voluntary recall in a June 6 letter, according to the notice posted to the FDA's Web site. Company representatives said they could not immediately provide further details on the action.
The FDA approved the Nexstent in 2006 for patients with clogged carotid arteries, which carry blood between the heart and the brain. The stent is made from a combination of nickel and titanium.
The use of bare-metal stents has gradually declined since 2003, when manufacturers introduced new drug-coated stents. Boston Scientific's best-selling product is the drug-coated Taxus stent, which had sales of $382 million in the last quarter.
Company shares already were pressured Thursday by a Wall Street Journal report claiming that Boston Scientific's studies of its next-generation Taxus Liberte stent are based on flawed data. According to the Journal, the company's analysis of its clinical trials gave undue advantage to the stent, which is sold in Europe.
Shares of Natick, Mass.-based Boston Scientific fell 22 cents to $13.16 in afternoon trading.
