Boston Scientific Flextome

The Boston Scientific Flextome Cutting Balloon system is used to open blocked arteries or blood vessels. It consists of a surgical balloon with microsurgical blades attached to the sides. The balloon is inserted into the artery with a catheter and dilated. When the balloon expands, the microblades cut through fat deposits and widens the blocked artery.

The Boston Scientific Flextome is subject to a Class I recall, which is the most urgent form of hazardous medical product recall. Class I recalls are restricted to situations in which there is a reasonable probability that use of the product will cause serious injury or death. 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.

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