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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/13/2010 - Recall Notice - FDA]