fell Friday as the company said it was recalling about 200 of its Taxus drug-coated stents.
The Natick, Mass.-based company said it made the move because of characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure ... which can result in significant patient complications, including coronary artery bypass graft surgery and death."
The company said it had informed the Food and Drug Administration, which has received reports of one death and 16 serious injuries associated with balloon deflation. A stent is a tiny device inserted into arteries to improve blood flow and reduce the risk of heart disease and heart attack.
Boston Scientific's Taxus stent was approved in March and has experienced strong sales as it competes with
Johnson & Johnson's
Cypher, which was the first to win approval for the U.S. market. Taxus was first launched outside the U.S. in 2003.
Other companies, including
, are developing drug-coated -- or drug eluting -- stents for world markets.
Boston Scientific said the stents had been shipped to 99 hospitals in the U.S., while 10 units were shipped to three Canadian hospitals
In its statement, the company emphasized that "the recall does not affect patients who have already received a Taxus stent, because the difficulty is with the delivery system and occurs at the time of insertion, not afterward."
Shares fell 70 cents, or 1.6%, to $42.