🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: March 22, 2017 Cook Medical Incorporated Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots. Catalog Numbers: ZTA-D-28-160-W ZTA-D-28-229-W ZTA-D-30-160-W ZTA-D-30-229-W ZTA-D-32-160-W ZTA-D-32-229-W ZTA-D-34-142-W ZTA-D-34-190-W ZTA-D-36-142-W ZTA-D-36-190-W ZTA-D-38-147-W ZTA-D-38-197-W ZTA-D-40-147-W ZTA-D-40-197-W ZTA-D-42-152-W ZTA-D-42-204-W ZTA-D-44-157-W ZTA-D-44-211-W ZTA-D-46-157-W ZTA-D-46-211-W ZTA-DE-18-104-W ZTA-DE-18-148-W ZTA-DE-20-104-W ZTA-DE-20-148-W ZTA-DE-22-104-W ZTA-DE-22-148-W ZTA-DE-24-104-W ZTA-DE-24-148-W ZTA-DE-26-104-W ZTA-DE-26-148-W ZTA-DE-28-108-W ZTA-DE-28-154-W ZTA-DE-30-108-W ZTA-DE-30-154-W ZTA-DE-32-108-W ZTA-DE-32-154-W ZTA-DE-34-112-W ZTA-DE-34-160-W ZTA-DE-36-112-W ZTA-DE-36-160-W ZTA-DE-38-141-W ZTA-DE-38-91-W ZTA-DE-40-141-W ZTA-DE-40-91-W ZTA-DE-42-146-W ZTA-DE-42-94-W ZTA-DE-44-151-W ZTA-DE-44-97-W ZTA-DE-46-151-W ZTA-DE-46-97-W ZTA-P-18-105-W ZTA-P-18-127-W ZTA-P-20-105-W ZTA-P-20-127-W ZTA-P-22-105-W ZTA-P-22-127-W ZTA-P-24-105-W ZTA-P-24-127-W ZTA-P-26-105-W ZTA-P-26-149-W ZTA-P-28-109-W ZTA-P-28-132-W ZTA-P-28-155-W ZTA-P-28-201-W ZTA-P-30-109-W ZTA-P-30-132-W ZTA-P-30-155-W ZTA-P-30-201-W ZTA-P-32-109-W ZTA-P-32-132-W ZTA-P-32-155-W ZTA-P-32-201-W ZTA-P-34-113-W ZTA-P-34-137-W ZTA-P-34-161-W ZTA-P-34-209-W ZTA-P-36-113-W ZTA-P-36-137-W ZTA-P-36-161-W ZTA-P-36-209-W ZTA-P-38-117-W ZTA-P-38-142-W ZTA-P-38-167-W ZTA-P-38-217-W ZTA-P-40-117-W ZTA-P-40-142-W ZTA-P-40-167-W ZTA-P-40-217-W ZTA-P-42-121-W ZTA-P-42-147-W ZTA-P-42-173-W ZTA-P-42-225-W ZTA-P-44-125-W ZTA-P-44-152-W ZTA-P-44-179-W ZTA-P-44-233-W ZTA-P-46-125-W ZTA-P-46-152-W ZTA-P-46-179-W ZTA-P-46-233-W ZTA-PT-22-18-105-W ZTA-PT-26-22-105-W ZTA-PT-30-26-108-W ZTA-PT-32-28-178-W ZTA-PT-32-28-201-W ZTA-PT-34-30-161-W ZTA-PT-34-30-209-W ZTA-PT-36-32-161-W ZTA-PT-36-32-209-W ZTA-PT-38-34-167-W ZTA-PT-38-34-217-W ZTA-PT-40-36-167-W ZTA-PT-40-36-217-W ZTA-PT-42-38-173-W ZTA-PT-42-38-225-W ZTA-PT-44-40-179-W ZTA-PT-44-40-233-W ZTA-PT-46-42-179-W ZTA-PT-46-42-233-W
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cook Medical Incorporated
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

All lots. Catalog Numbers: ZTA-D-28-160-W ZTA-D-28-229-W ZTA-D-30-160-W ZTA-D-30-229-W ZTA-D-32-160-W ZTA-D-32-229-W ZTA-D-34-142-W ZTA-D-34-190-W ZTA-D-36-142-W ZTA-D-36-190-W ZTA-D-38-147-W ZTA-D-38-197-W ZTA-D-40-147-W ZTA-D-40-197-W ZTA-D-42-152-W ZTA-D-42-204-W ZTA-D-44-157-W ZTA-D-44-211-W ZTA-D-46-157-W ZTA-D-46-211-W ZTA-DE-18-104-W ZTA-DE-18-148-W ZTA-DE-20-104-W ZTA-DE-20-148-W ZTA-DE-22-104-W ZTA-DE-22-148-W ZTA-DE-24-104-W ZTA-DE-24-148-W ZTA-DE-26-104-W ZTA-DE-26-148-W ZTA-DE-28-108-W ZTA-DE-28-154-W ZTA-DE-30-108-W ZTA-DE-30-154-W ZTA-DE-32-108-W ZTA-DE-32-154-W ZTA-DE-34-112-W ZTA-DE-34-160-W ZTA-DE-36-112-W ZTA-DE-36-160-W ZTA-DE-38-141-W ZTA-DE-38-91-W ZTA-DE-40-141-W ZTA-DE-40-91-W ZTA-DE-42-146-W ZTA-DE-42-94-W ZTA-DE-44-151-W ZTA-DE-44-97-W ZTA-DE-46-151-W ZTA-DE-46-97-W ZTA-P-18-105-W ZTA-P-18-127-W ZTA-P-20-105-W ZTA-P-20-127-W ZTA-P-22-105-W ZTA-P-22-127-W ZTA-P-24-105-W ZTA-P-24-127-W ZTA-P-26-105-W ZTA-P-26-149-W ZTA-P-28-109-W ZTA-P-28-132-W ZTA-P-28-155-W ZTA-P-28-201-W ZTA-P-30-109-W ZTA-P-30-132-W ZTA-P-30-155-W ZTA-P-30-201-W ZTA-P-32-109-W ZTA-P-32-132-W ZTA-P-32-155-W ZTA-P-32-201-W ZTA-P-34-113-W ZTA-P-34-137-W ZTA-P-34-161-W ZTA-P-34-209-W ZTA-P-36-113-W ZTA-P-36-137-W ZTA-P-36-161-W ZTA-P-36-209-W ZTA-P-38-117-W ZTA-P-38-142-W ZTA-P-38-167-W ZTA-P-38-217-W ZTA-P-40-117-W ZTA-P-40-142-W ZTA-P-40-167-W ZTA-P-40-217-W ZTA-P-42-121-W ZTA-P-42-147-W ZTA-P-42-173-W ZTA-P-42-225-W ZTA-P-44-125-W ZTA-P-44-152-W ZTA-P-44-179-W ZTA-P-44-233-W ZTA-P-46-125-W ZTA-P-46-152-W ZTA-P-46-179-W ZTA-P-46-233-W ZTA-PT-22-18-105-W ZTA-PT-26-22-105-W ZTA-PT-30-26-108-W ZTA-PT-32-28-178-W ZTA-PT-32-28-201-W ZTA-PT-34-30-161-W ZTA-PT-34-30-209-W ZTA-PT-36-32-161-W ZTA-PT-36-32-209-W ZTA-PT-38-34-167-W ZTA-PT-38-34-217-W ZTA-PT-40-36-167-W ZTA-PT-40-36-217-W ZTA-PT-42-38-173-W ZTA-PT-42-38-225-W ZTA-PT-44-40-179-W ZTA-PT-44-40-233-W ZTA-PT-46-42-179-W ZTA-PT-46-42-233-W

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2099-2017

Related Recalls

Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W

Cook Medical Incorporated

Class I - Dangerous

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

Sep 18, 2025 Other Medical Devices Nationwide View Details →