FDAnews Device Daily Bulletin


Dec. 9, 2005

Boston Scientific has voluntarily recalled all of its Flextome balloon-cutting systems, which are used to help open blocked arteries, because of reported flaws with the device.

The recall of roughly 40,000 devices affects the Flextome Cutting Balloon Device Monorail Delivery System and Peripheral Cutting Balloon Microsurgical Dilatation Device Small Monorail Delivery System. The products generated revenues of approximately $13 million in 2005, Boston Scientific said.

Boston Scientific's decision stems from reported problems with the distal shaft of the catheter, which may separate during withdrawal of the device. A shaft separation may prolong the procedure or require additional surgery. The firm said it had received eight complaints from patients, of which three required surgery. The recall does not affect patients who have already received treatment because the potential problem occurs during the procedure, the Boston Scientific said.

The balloon-cutting device consists of an angioplasty balloon with microsurgical blades -- called atherotomes -- mounted to the balloon surface. As the balloon is expanded, the atherotomes score the lesions with incisions, allowing the balloon to dilate the vessel with less pressure. Balloon angioplasty is often used to open blocked arteries or vessels.

The products affected by this recall were distributed to hospitals worldwide. Boston Scientific is notifying affected hospitals through detailed recall notification letters, including instructions on how to return recalled products. The firm is also working with the FDA and is notifying officials in other countries.

This is the second time Boston Scientific has had to withdrawal a device because of balloon-related problems. The firm recalled nearly 100,000 Taxus drug-eluting stents in 2004 due to a manufacturing problem that inhibited deflation of the angioplasty balloon in the stent's catheter delivery system. The problem had been linked to three deaths and 47 serious injuries.

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