Medical device maker Boston Scientific Corp. said Thursday it is recalling 40,000 implantable devices meant to treat blocked coronary arteries, saying it has received eight complaints that the end of the device became detached as it was inserted in the patient and required more surgery in three cases.
The recall affects all of its Flextome cutting angioplasty balloon devices that the Food and Drug Administration approved as recently as September.
The device differs from standard angioplasty balloons in that it is lined on the outside with three or four 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.
Boston Scientific said it received eight complaints that the device tip separated from the catheter as it was removed from the patient, and said surgery was needed in three cases to remove the tip.
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 booked $13 million in Flextome sales in 2005.
This is the second recall of a balloon-related device in as many years for Boston Scientific. The company recalled thousands of its Taxus Express2 drug-coated stents last summer after reports that the balloon used to place the stent did not deflate in some instances causing injury to the patient.
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 that the capsule carrying the filter during implantation became detached from the delivery system, causing one patient death.
