FDA MedWatch - Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Recall Correction and Removal of Specific Sizes from Market - Increased Reports of Graft Thrombosis and Occlusion in BTAI Treatment

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Cook Medical: Recall Correction and Removal of Specific Sizes from Market - Increased Reports of Graft Thrombosis and Occlusion in BTAI Treatment

AUDIENCE: Cardiology, Surgery, Radiology, Risk Manager

ISSUE: Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase.

BACKGROUND: Cook Medical has notified its customers and distributors by Medical Device Correction and Removal letters. All customers and distributors were informed to follow the IFU corrections, quarantine and discontinue use of the recalled sizes, and return that affected product to Cook as soon as possible for credit.

RECOMMENDATION: Consumers with questions or concerns should contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time.

Adverse events may also be reported to Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email atCustomerRelationsNA@CookMedical.com.
 

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
• 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

Read the MedWatch safety alert, including links to the Recall Notice, at https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm573724.htm