Boston Scientific Recalls Angioplasty Devices

A worldwide recall of balloon angioplasty devices meant to treat blocked coronary arteries was announced in December 2005 by Boston Scientific (Natick, MA, USA).

The recall, involving about 40,000 Flextome cutting angioplasty balloon devices, came after the company said it had received eight reports that the distal shaft of the catheter may separate during withdrawal of the device. In three of the cases, surgery was required to remove the detached end. Boston Scientific said it was working with the U.S. Food and Drug Administration (FDA) on the recall and is also notifying health officials in other countries.

The products recalled are the Flextome cutting balloon device monorail delivery system and the peripheral cutting balloon microsurgical dilatation device small monorail delivery system. Angioplasty balloons are used to reopen narrowed arteries and push back accumulated plaque in the arteries. The Flextome device differs from standard angioplasty balloons in having three or four microsurgical blades (called atherotomes) on its exterior.

This is the second recall of a Boston Scientific device within a week. Last week, the company announced a recall of about 18,000 stainless steel Greenfield vena cava filters designed to filter and dissolve blood clots in order to protect the lungs.



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