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# Cook Medical Corrects Instructions on Endovascular Graft
- URL: https://www.fdaweb.com/cook-medical-corrects-instructions-on-endovascular-graft/
- Published: 2017-08-28T12:00:00.000Z
- Updated: 2026-09-14T22:44:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139489

FDA says Cook Medical has initiated a correction to its “instructions for use” for the Zenith Alpha Thoracic Endovascular Graft. The correction removes the indication for blunt thoracic aortic injury or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically when treating this, according to a [recall notice](https://www.fda.gov/Safety/Recalls/ucm573226.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery). Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device, which are used for blunt thoracic aortic injuries.