FDA Class 1 Recall for 6 French Engage Introducer Devices
August 18, 2010
The FDA has issued a class I recall notice for St. Jude 6 French EngageTM Introducer devices produced between April 27 and June 3, 2010. This recall affects approximately 5,120 devices.
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.
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 the 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