# FDA recall Z-2546-2020

> **Cook Inc.** · Class II · device recall initiated 2020-06-02.

## Product

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.

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-2546-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-02
- **Report date:** 2020-07-15
- **Termination date:** 2022-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2546-2020

## Citation

> AI Analytics. FDA recall Z-2546-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2546-2020. Source: US FDA. Licensed CC0.

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