Boston Scientific Corp. said Friday it is recalling 200 of its recently approved drug-coated coronary stents because of a malfunction that has been blamed for at least one death.
The medical-equipment maker attributed the malfunction to a manufacturing defect that has since been fixed.
A stent is a wire-mesh tube inserted into a heart artery to keep it propped open after the vessel is cleared of a blockage. Some stents are coated with slow-release drugs to prevent scar tissue from creating a new blockage.
Balloon may not deflate
A tiny balloon is used to expand the stent inside the artery. But Boston Scientific said a malfunction can prevent the balloon from deflating after it has been used. That can result in death or require bypass surgery.
Boston Scientific reported one death and 16 serious injuries from such a deflation failure to the Food and Drug Administration. But the company said it found the problem in only two recent manufacturing lots of the Taxus Express2 stents.
The recall does not affect patients who have already received a Taxus stent, because the problem turns up only at the time it is implanted. About 445,000 of the stents have been implanted, spokesman Paul Donovan said.
Boston Scientific said it voluntarily recalled the 200 defective stents after detecting the problem through its quality-control process.
The company is notifying the 99 U.S. hospitals and three Canadian hospitals that have received the recalled stents. Company officials said they did not know whether any of the stents had already been implanted.
Boston Scientific received approval from regulators in March to sell the Taxus in the United States. The stent was launched in Europe in 2003.