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U.S. Department of Health and Human Services

Medical Devices

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Boston Scientific Flextome® Cutting Balloon Systems

Class 1 Recall
Date Recall
Initiated:
 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

 
FDA District:

Los Angeles

 
FDA Comments:
  • This product should no longer be used on patients and should be returned to Boston Scientific.
  • This action does not affect patients who have already received treatment, because the problem occurs during the procedure.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

 
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