AUDIENCE: Risk Manager, Cardiology, Surgery
ISSUE: Cordis and FDA notified healthcare professionals and their organizations of a product labeling correction to provide clarification and additional information to minimize likelihood of implanting the filter backwards. This recall covers 33,000 units distributed in the United States between 05/06/2010 and 04/02/2013.
BACKGROUND: The Optease Retrievable Vena Cava Filter is used for the prevention of recurrent pulmonary embolism in patients under specific situations. The device is implanted into the inferior vena cava and is designed to be retrieved when the patient no longer requires a filter.
RECOMMENDATION: On 4/3/2013, Cordis Corporation sent an "URGENT Medical Device Correction" letter to their customers in the U.S. and Canada. Customers were instructed to read the description and recommendations sections of the Instructions for Use then sign and return an Acknowledgement Form directly to Cordis.
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
[08/08/2013 - Recall Notice - FDA]