Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Coil
AUDIENCE: Risk Managers, Surgery, Emergency Medicine
ISSUE: The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.
BACKGROUND: The Penumbra Coil 400 is a small platinum coil placed into a brain aneurysm through the blood vessels leading to the brain. Once the device is in place, the body responds by forming a blood clot around the coil mass, which occludes the aneurysm and helps protect the blood vessel from rupturing or leaking.
RECOMMENDATION: On March 4, 2011, Penumbra, Inc. notified their customers and distributors of the recall and instructed to return the product to the company.
Healthcare professionals and patients 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