Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Recalled by Cook Medical Incorporated Due to There have been five reports of graft thrombosis/occlusion...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Medical Incorporated directly.
Affected Products
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " Iliac/femoral anatomy that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.
Quantity: 4916
Why Was This Recalled?
There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Medical Incorporated
Cook Medical Incorporated has 53 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report