6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub
MedSun: Newsletter #52, September 2010

FDA MedWatch Safety Alert

Some devices in the affected batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly. If either of these were to occur during use, a potentially life threatening episode of bleeding could occur.

Additional Information:

FDA MedWatch Safety Alert. French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub. August 13, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222397.htm