FDA Alerts on Boston Scientific Balloon Devices

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Class 1 Recall: Boston Scientific Flextome® Cutting Balloon System
December 7, 2005

Product:
Flextome Cutting Balloon® Device Monorail® Delivery System

Use:
The 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 then dilated. When the balloon expands, the microblades cut through fatty deposits, widening the blocked artery.

Recalling Firm:
Boston Scientific Corporation
3574 Ruffin Road
San Diego, California 92123-2597

Reason for Recall:
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.

Public Contact:
Abe Matthews
Vice President of Regulatory Affairs
Boston Scientific Corporation
3574 Ruffin Road
San Diego, California 92123-2597
858-254-7885

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