A Medical Device Daily

Cordis (Miami Lakes, Florida), a subsidiary of Johnson & Johnson (J&J; New Brunswick, New Jersey), late last week reported that it had voluntarily withdrawn 300 of its Cypher stents from the U.S. market after determining that the coating on six of the devices did not meet specifications.

The Cypher stent is a tiny wire mesh tubular device that props open surgically cleared arteries. It is coated with a drug that prevents the arteries from reclogging with scar tissue.

“There is no safety issue,“ said company spokeswoman Terri Mueller in a Reuters report. “We are committed to quality and are being overcautious.“

The withdrawal involved 145 customers, the company said.

Mueller said the company did not know if any of the stents had been used in patients, but stressed that medical evaluation has found that the small weight difference of the six stents is not expected to affect clinical performance.

At this point, the recall pales in comparison to that of rival Boston Scientific (Natick, Massachusetts), which last summer had to recall a vastly larger number of its Taxus stents because of manufacturing problems. The company recalled about 88,000 of its Taxus drug-eluting stents, as well as 11,000 bare-metal Taxus Express2 stents between July and August of 2004.

J&J and Boston Scientific are the only two companies with approval to sell drug-coated stents in the U.S. While J&J was first to market with its product, Boston Scientific has assumed market leadership.