Parker, Waichman, Alonso LLP

Home » Topics » Defective Medical Devices » Boston Scientific Flextome

Boston Scientific Flextome

Medical device maker Boston Scientific Corp. is recalling 40,000 implantable devices meant to treat blocked coronary arteries, saying they have received eight complaints that the end of the device became detached as it was inserted in the patient and required more surgery in three of the cases.

The recall affects all of its Flextome cutting angioplasty balloon devices that the Food and Drug Administration (FDA) 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 micro-surgical blades. 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.

If you or a loved one suffered injuries from a Boston Scientific Flextome device, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.