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U.S. Department of Health and Human Services

Safety

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Boston Scientific Flextome Cutting Balloon Systems

Audience: Interventional cardiology healthcare professionals and risk managers

[Posted 02/02/2006] Boston Scientific and FDA notified healthcare professionals of the class 1 recall of the Flextome Cutting Balloon system, used to open blocked arteries or blood vessels. The catheter shaft used to place the balloon in the artery may separate during withdrawal of the device from the patient. If that happens, the procedure may be prolonged, or more in-depth surgery may be required to remove the broken-off piece from the artery.

[January 31, 2006 – Recall Notice – FDA]