Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZT
FDA device recall Z-0043-2026 · posted 2025-10-10 · Open, Classified
Recall details
- Recalling firm
- Cook Medical Incorporated
- Reason for recall
- Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
- Action taken
- On September 18, 2025, the recalling firm sent Urgent Medical Device Recall letters to all affected customers. Customers were instructed to identify and quarantine unused affected product in inventory. Immediately cease all further distribution and use of the affected products. Affected product is to be returned to Cook Medical.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- MIH
- Quantity affected
- 695
- 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
- Date initiated
- 2025-09-18
- Date posted
- 2025-10-10
- Location
- Bloomington, IN
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