Boston Scientific announced a wider recall of its recently approved drug-coated coronary stent Friday, as well as a recall of another stent. Shares in Boston Scientific sank 13 percent.
The company recalled 200 units of the Taxus Express2 stent on July 2 because of a problem with a tiny balloon placed inside arteries to inflate the stent once it has been surgically moved into place.
On Friday, the company said further analysis had identified additional production lots that may have the same problem.
The recall will involve about 85,000 Taxus stent systems and about 11,000 Express2 stent systems. Overall, Boston Scientific has shipped more than 500,000 Taxus stent systems and more than 600,000 Express2 stent systems.
Boston Scientific said in a news release that it has received reports of one death and 18 serious injuries associated with balloon deflation for the Taxus stent system, and two deaths and 25 serious injuries associated with balloon deflation in the Express2. The units being recalled were manufactured at the firm’s facilities in Galway, Ireland, and Maple Grove, Minn.
“Patient safety continues to be our highest priority,” president and chief executive Jim Tobin said in a statement. “We have every confidence these products are safe and effective, and we expect that these measures will go a long way toward reducing the occurrence of these events.”
Trading was halted most of the day Friday. When trading began shortly before the market closed, the shares sank $5.43 to $35.06 on the New York Stock Exchange.
The company said that current inventory levels will minimize disruption in the United States, but that they expect some disruption elsewhere around the world.
The recall does not affect the Express SD and LD biliary stent systems.