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: |
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. |
A copy of the company's press release regarding this recall can be found on the company's website. |
Updated January 31, 2006
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