Use cautionMedical device recall · FDA · Published June 2, 2020
Cook Zenith Alpha Abdominal Endovascular Graft Recall: Damaged Bushing May Cause
Cook recalls Zenith Alpha Abdominal Endovascular Grafts with catalog prefix ZIMB due to potential damaged bushing that could prevent proper deployment. Affected units may need replacement.
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.
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📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer
Cook is recalling certain Zenith Alpha Abdominal Endovascular Grafts (catalog prefix ZIMB) because some units may have a damaged bushing that could prevent the graft from deploying correctly. This could lead to treatment failure for patients needing endovascular repair of abdominal aortic or aorto-iliac aneurysms. Read more at govinfonow.com/recall/65069-cook-zenith-alpha-abdominal-endovascular-graft-recall-damaged-bushing-may.
“Cook Zenith Alpha Abdominal Endovascular Graft Recall: Damaged Bushing May Cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65069-cook-zenith-alpha-abdominal-endovascular-graft-recall-damaged-bushing-may. Based on FDA recall #Z-2546-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2546-2020%22&limit=1).
Cook Inc. recalled Zenith Alpha Abdominal Endovascular Grafts with catalog prefix ZIMB on June 2, 2020, according to the FDA. The agency announced the recall because damaged bushings could prevent full deployment of the graft.
The FDA said identified products may contain a damaged bushing within the delivery system. This defect could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the instructions for use.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls of similar products include Cook Flexor Check-Flo Introducer Ansel Modification Recall (Nov. 12, 2021), Cook Skinny Needle with Chiba Tip Recall (Oct. 13, 2021), and Cook Transseptal Needle Recall (Oct. 8, 2021). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), Cook Ring Transjugular Intrahepatic Access Sets Recall (Nov. 26, 2025), and Cook Rupsch-Uchida Liver Access Sets Recall (Nov. 26, 2025).
How to tell if you have this one
Check for the catalog prefix ZIMB on the product label. This recall applies to specific units sold for endovascular treatment of abdominal aortic or aorto-iliac aneurysms.
Brand
Cook
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Cook Inc. to confirm if your specific graft is affected and get instructions for replacement.
How this recall unfolded
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
No, but affected units should not be used until replaced. The recall does not require immediate discontinuation but replacement is needed for affected units.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2546-2020 (June 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2546-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.