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Boston Scientific Taxus Stent

Boston Scientific Corp., the largest maker of heart stents, expanded a voluntary recall of its drug-coated Taxus devices because of possible defects in the delivery system. The recall involved approximately 85,000 Taxus stents. About 200 Taxus stents were recalled initially.

The drug-coated coronary stent system has been linked to one death and 16 "serious" injuries. The company said it has received 42 complaints, of which only 30 Taxus systems showed actual performance flaws. The catheter problems appear to have been caused when too much heat was applied during the laser welding stage in the manufacturing process, the company said.

Brigham & Women's Hospital in Massachusetts, one of the nation's leading hospitals, pulled Boston Scientific Corp.'s popular Taxus stent from its shelves two weeks after the recall. The action by Brigham & Women's, which is affiliated with Harvard Medical School, suggested to some doctors the recall may have had greater ramifications than originally thought.

"I would doubt that any problem like this would be confined to a single lot; I suspect there's more to come," said Dr. Eric Topol, chair of cardiovascular medicine of the Cleveland Clinic in Ohio.
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