Boston Scientific Has Second Recall

By Associated Press

NEW YORK — Boston Scientific Corp. said Thursday it is recalling 40,000 devices used to treat blocked coronary arteries, saying it has received eight complaints that the end of the device became detached as it was removed from the patient, requiring more surgery in three cases.

The recall affects all Flextome cutting angioplasty balloon devices that the Food and Drug Administration approved in September.

The recall marks Boston Scientific’s second within a week. On Friday, the company announced the recall of about 18,000 devices that filter and dissolve blood clots from entering the lungs. The recall was triggered by eight complaints and one patient death.

The Flextome device differs from standard angioplasty balloons in that it is lined on the outside with lengthwise microsurgical blades. During angioplasty, a balloon catheter is snaked into a congested artery and inflated to reopen the blood vessel and push back accumulated plaque. The blades on the Flextome cut the fibrous plaque as the balloon inflates, allowing for an easier compression.

The company said it is working with the FDA on the recall and notifying officials from other countries. The Flextome was approved in Europe in January. Boston Scientific has booked $13 million in Flextome sales during the year.

Piper Jaffray analyst Thom Gunderson said in an interview that the recall is small from a financial standpoint, and that more frequent recalls have become the new reality in the medical device industry.

“We have moved in the last six months to a new level of watchfulness for medical devices, so if the level of scrutiny goes up we’re going to have to readjust to more recalls for tinier problems,” Gunderson said. “The good news is they found the problem, the bad news is they had to find the problem in the field.”

The company suffered balloon-related problems last summer when it had to recall thousands of its Taxus Express2 drug-coated stents after reports that the balloon used to place the stent did not deflate in some instances causing injury to the patient.

The announcement comes after Boston Scientific made a $25 billion offer Monday for rival medical device maker Guidant Corp., potentially derailing Guidant’s plans to be acquired at a lower price by Johnson & Johnson. J&J had lowered its price for Guidant in part because the Indianapolis-based company had recalled thousands of its pacemakers and implantable heart defibrillators over the summer.