# FDA recall Z-2964-2020

> **Cook Inc.** · Class II · device recall initiated 2020-08-11.

## Product

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only.  Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms    Reference Part Number (RPN):  ZIMB-22-108  ZIMB-22-118  ZIMB-22-128  ZIMB-22-70  ZIMB-22-84  ZIMB-22-98  ZIMB-24-108  ZIMB-24-118  ZIMB-24-128  ZIMB-24-70  ZIMB-24-84  ZIMB-24-98  ZIMB-26-108  ZIMB-26-118  ZIMB-26-128  ZIMB-26-70  ZIMB-26-84  ZIMB-26-98  ZIMB-28-108  ZIMB-28-118  ZIMB-28-128  ZIMB-28-70  ZIMB-28-84  ZIMB-28-98  ZIMB-30-108  ZIMB-30-118  ZIMB-30-128  ZIMB-30-70  ZIMB-30-84  ZIMB-30-98  ZIMB-32-108  ZIMB-32-108  ZIMB-32-118  ZIMB-32-128  ZIMB-32-70  ZIMB-32-84  ZIMB-32-98  ZIMB-36-108  ZIMB-36-118  ZIMB-36-128  ZIMB-36-84  ZIMB-36-98

## Reason for recall

May contain excess glue within the handle of the delivery system, resulting in an inability to fully  deploy the graft via the standard method or troubleshooting deployment method provided in the IFU

## Distribution

Foreign Only:   Canada  SWEDEN  AUSTRIA  Belgium  CZECH REPUBLIC  DENMARK  ESPA¿A  FINLAND  France  GERMANY  GREECE  HUNGARY  IRELAND  ISRAEL  Italia  Nederland  NORWAY  POLAND  PORTUGAL  REUNION  SERBIA  SLOVENIA  SOUTH AFRICA  SWEDEN  UNITED ARAB EMIRATES  UNITED KINGDOM    AUSTRALIA  Hong Kong  JAPAN  NEW CALEDONIA  New Zealand  Thailand

## Key facts

- **Recall number:** Z-2964-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-11
- **Report date:** 2020-09-23
- **Termination date:** 2021-07-28

- **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-2964-2020

## Citation

> AI Analytics. FDA recall Z-2964-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2964-2020. Source: US FDA. Licensed CC0.

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