Zenith Alpha Thoracic Endovascular Graft The Zenith recall
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with…
Why was Zenith Alpha Thoracic Endovascular Graft The Zenith 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with…
- Recalling firm
- Cook Medical Incorporated
- Quantity
- 4916
- Distribution
- Nationwide Distribution.
- Recall date
- August 16, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)