FDA: Boston Scientific recalls Chariot Guiding Sheath

Editor's Note

The Food and Drug Administration on December 11 announced that Boston Scientific (Marlborough, Massachusetts) recalled its Chariot Guiding Sheath because of the risk of shaft separation.

The company received 14 complaints of shaft separation, four of which involved separation of the distal shaft.

The Sheath is used to introduce interventional devices during peripheral vascular procedures. 

Posted 12/11/2015] AUDIENCE: Risk Manager, Surgery ISSUE: Boston Scientific has voluntarily recalled the Chariot Guiding Sheath globally. The recall affects all UPNs of the Chariot Guiding Sheaths. The recall was initiated on November 19, 2015 due to the risk of shaft separation.