Reported Aug 16, 2017 · Terminated

Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the…

Cook Medical Incorporated

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Medical Incorporated · 400 N Daniels Way · Bloomington, IN · 47404-9155

Is this the product you have?

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

Lot codes and dates: All lots
Catalog Numbers
119 of 119 codes
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
Amount recalled: 4916

Where it was sold

Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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