Boston Scientific Recalls 200 Taxus Stent Systems

Boston Scientific Corp. on Friday said it has recalled about 200 drug-coated heart stents after one patient died and 16 were seriously injured due to a malfunction in the mechanism used to implant the device.

The Natick, Massachusetts-based company issued the recall after the U.S. Food and Drug Administration informed it of the death and injuries related to its Taxus stent, which the company launched in early March.

Boston Scientific Chief Executive Jim Tobin downplayed the recall. “It’s no more and no less that what we’ve put in the press release. I don’t believe this to be a tip of the iceberg situation,” Tobin said on a conference call.

Taxus was the second such device to enter the lucrative U.S. market behind Johnson & Johnson’s Cypher stent. Boston Scientific has said Taxus controlled more than 70 percent of the market in the first few months of its launch.

The problem with the Taxus stent is due to the delivery catheters that have the potential to impede the deflation of the balloon during coronary angioplasty procedures, the company said. If the balloon fails to deflate properly it can cause complications, including death and the need for coronary artery bypass graft surgery.

The defects were found in two manufacturing lots, which had been shipped to 99 hospitals in the United States. Ten of the stents were shipped to three Canadian hospitals. The company said the recall does not affect patients who have already had a stent implanted.

Boston Scientific in the conference call said it made two manufacturing changes in April and May and said the lots involved in the recall were shipped before the changes were made.

Dr. Gary Schaer, director of the cardiac catheterization laboratories at Rush University Medical Center in Chicago, said the recall may not reflect the scope of the problem. “I think it is more widespread. Most cardiologists I have spoken with about this have experienced it in one form or another.”

Schaer said he and his colleagues have experienced problems when deflating the balloon catheter.

“On occasion, it has required us to reinflate and deflate more slowly to get the balloon deflated and retrieve the balloon from the vessel. I’ve heard of cases at other institutions where the balloon would not deflate and needed to be removed surgically. That has not happened here,” he said.

Schaer said none of the cases in his facility were reported to the FDA. An FDA spokeswoman said the agency had no comment.

Schaer said the recall could affect use of the Taxus stent.

“I think in the minds of some cardiologists, this presents a concern that may result in less Taxus and more Cypher use. We have been seeing some change in market share based on these concerns,” he said.

The Taxus stent made huge market share gains in a short period of time because doctors considered it easier to implant in patients.

The company said it notified the FDA of the recall.