Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Zenith Alpha Abdominal Endovascular Graft Recalled by Cook Inc. Due to Identified products may contain a damaged bushing within...

Date: June 2, 2020
Company: Cook Inc.
Status: Terminated
Source: FDA (Device)

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 Inc. directly.

Affected Products

Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.

Quantity: 571

Why Was This Recalled?

Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.

Where Was This Sold?

Foreign distribution to the countries of Canada, Chile, Argentina, Colombia, Great Britain, AUSTRIA Belgium. CZECH REPUBLIC DENMARK ESPA¿A France GERMANY GREECE HUNGARY ICELAND IRELAND ISRAEL Italia MARTINIQUE Nederland NORWAY POLAND PORTUGAL SERBIA SOUTH AFRICA SWEDEN UNITED KINGDOM Australia Hong Kong Thailand

About Cook Inc.

Cook Inc. has 262 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report