Boston Scientific recalls 40,000 angioplasty devices

Manufacturing News, Source : TheManufacturer.com
Published : 08 Dec 2005 21:31

Boston Scientific announced that it was recalling 40,000 Flextome Cutting Balloon systems, used to penetrate fatty deposits in diseased arteries, due to malfunctions reported during surgical procedures.

The company is initiating the recall because it received complaints and testing that the distal shaft of the catheter may separate during withdrawal of the device. A shaft separation may prolong the procedure or require additional surgery. A total of eight complaints involving patients have been received by the company, of which three required additional surgery. The recall does not affect patients who have already received treatment with the recalled devices, because the potential problem occurs during the surgery itself.

The Cutting Balloon system consists of an angioplasty balloon with microsurgical blades called atherotomes mounted to the balloon’s 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 used to open blocked arteries or vessels.

Earlier this week, Boston Scientific bid $25 billion for medical device maker Guidant, which has also experiences several device recalls. Boston Scientific's Flextome system has so far generated revenues of approximately $13 million year to date in 2005.

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