# FDA recall Z-0043-2026

> **Cook Medical Incorporated** · Class I · device recall initiated 2025-09-18.

## Product

Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2-    Reference Part Numbers  ZTA2-P-40-117-W  ZTA2-P-40-167  ZTA2-P-40-167-W  ZTA2-P-40-217-W  ZTA2-P-42-121  ZTA2-P-42-121-W  ZTA2-P-42-173  ZTA2-P-42-173-W  ZTA2-P-42-225  ZTA2-P-42-225-W  ZTA2-P-44-125  ZTA2-P-44-125-W  ZTA2-P-44-179  ZTA2-P-44-179-W  ZTA2-P-44-233  ZTA2-P-44-233-W  ZTA2-P-46-125  ZTA2-P-46-125-W  ZTA2-P-46-179  ZTA2-P-46-179-W  ZTA2-P-46-233-W  ZTA2-PT-40-36-167  ZTA2-PT-40-36-167-W  ZTA2-PT-40-36-217  ZTA2-PT-40-36-217-W  ZTA2-PT-42-38-173  ZTA2-PT-42-38-173-W  ZTA2-PT-42-38-225  ZTA2-PT-42-38-225-W  ZTA2-PT-44-40-179  ZTA2-PT-44-40-179-W  ZTA2-PT-44-40-233-W  ZTA2-PT-46-42-179  ZTA2-PT-46-42-179-W  ZTA2-PT-46-42-233  ZTA2-PT-46-42-233-W  ZTA2-P-46-233  ZTA2-PT-44-40-233  ZTA2-P-40-217  ZTA2-P-40-117  ZTA2-P-40-167-DEMO  ZTA2-P-44-152-W  ZTA2-P-40-142  ZTA2-P-44-152  ZTA2-P-40-142-W

## Reason for recall

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

## Distribution

Domestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC NJ NY OH OR PA SC TN TX UT VA WA WI WV   International distribution to Switzerland, Germany, Italy, Poland, and Sweden

## Key facts

- **Recall number:** Z-0043-2026
- **Recalling firm:** Cook Medical Incorporated
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-18
- **Report date:** 2025-10-22

- **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-0043-2026

## Citation

> AI Analytics. FDA recall Z-0043-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0043-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*