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 will involve approximately 85,000 Taxus stents. About 200 Taxus stents were also recalled.
The company first described the problems with Taxus publicly in April and quickly instituted changes to the balloon design. On July 2, it said it would recall 200 Taxus systems it already had shipped. They were part of production batches in which the hole between the catheter and balloon was too small, apparently because the plastic material was stretched during a laser-welding process used in manufacturing.
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.
Patients who already have received the recalled stents are not at risk, doctors said yesterday. Blaming production problems, the company said the problems lie in the system used to implant the stent inside an artery. Stents are small, wire-mesh tubes used to prop open clogged arteries, and are put into place through a procedure known as angioplasty.
The company has previously disclosed other reports of cases in which the balloons seemed to stick to the cardiac stents, perhaps because of the drug coating, and were hard to withdraw. It did not specify the number of adverse events linked to the problem, which is also under FDA review.