Boston Scientific Corp. said Friday it is recalling 200 of its recently approved drug-eluting coronary stents because of a malfunction that has been blamed for at least one death.
The medical-equipment maker said the malfunction involves a small fraction of the nearly half-million stents implanted in heart patients. It blamed the problem on a manufacturing defect that has since been fixed.
Shares of Boston Scientific, the leader in the drug-coated stent market, were down 26 cents to $42.22 on the New York Stock Exchange.
The defect can prevent a tiny balloon from deflating after it is used to expand the stent, a metal-mesh tube inserted into coronary arteries to clear blockages.
Boston Scientific's Taxus Express2 stent is one of two next-generation stents on the market that are coated with slow-release drugs to prevent scar tissue from forming new blockages after surgery.
The company said it reported one death and 16 serious injuries from such deflation failures to the Food and Drug Administration.
But the company said it found the problem in only two lots shipped since the stent won FDA clearance for U.S. sales on March 4.
The stent has been on the market in Europe since February 2003, with 445,000 implanted in patients worldwide, Boston Scientific said.
The balloons are intended to deflate so they can more easily be withdrawn from the body during surgery. The failure to deflate can result in death or require coronary artery bypass surgery, the company said.
The recall does not affect patients who have already received a Taxus stent because the problem turns up only during surgery when doctors withdraw the balloon through a flexible plastic tube inserted into the body for the surgery.
"There is no post-procedural problem," said Paul Donovan, a spokesman for Natick-based Boston Scientific. "If you have a Taxus stent today, you are fine."
The company believes the balloon problem was the result of a manufacturing defect involving laser-welding of a stent's balloon to the plastic insertion tube. Boston Scientific won approval from the FDA in May to modify its manufacturing process to prevent further problems, Donovan said.
The company said the balloon problem has been the subject of 30 complaints from doctors.
FDA spokeswoman Sharon Snider said the agency was monitoring the company's voluntary recall. She declined further comment.
John Calcagnini, an industry analyst from CIBC World Markets, said he did not expect the recall to erode Boston Scientific's share of the drug-coated stent market, which is more than 70%.
"The product (Taxus) stent is very well-liked by doctors, and this (recall) appears to be a very isolated incident," Calcagnini said.
Boston Scientific said it sent notification about the recall to the 99 U.S. hospitals and three Canadian hospitals that have received shipments of the stent from the recalled lots. Donovan said he did not know whether any of those stents had been implanted.
In a conference call with analysts, Boston Scientific executives said the Taxus yielded $210 million in worldwide sales in June, up from $98 million during its first month on the market in March.
The only other drug-coated stent on the market is Johnson & Johnson's Cypher. Rivals such as Medtronic Corp. and Guidant Corp. hope in the next few years to introduce drug-coated stents they are developing into a global market that some industry estimates project could reach $6 billion by 2006.
J&J's stent also has had problems. In April, the FDA warned the company to quickly resolve problems with testing and documentation on Cypher stents manufactured in five different plants.