[pending] Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-4
Pending LLM rewrite. Source: FDA_DEVICE Z-0043-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
The recalled product
- 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-44-1
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Devices
Distribution
Distributed in 31 states:
- 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
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