6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub
Posted Aug 13 2010 11:35am
AUDIENCE: Risk Manager, Surgery, Cardiology
ISSUE: 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.
BACKGROUND: The Engage Introducer is used to implant catheters and electrodes into blood vessels during surgery and helps to prevent blood loss. Affected batches of the Engage Introducer were produced between April 27 and June 03, 2010. The recall affects approximately 5,120 devices.
RECOMMENDATION: Customers were advised by the recalling firm to discontinue the use of the affected product.
Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: