Cook Medical Incorporated medical device recall: Zenith Alpha 2 Thoracic Endovascular Graft
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97615
- Recall initiated
- Sep 18, 2025
- Classified by FDA
- Oct 10, 2025
- Posted in Enforcement Report
- Oct 22, 2025
- Recalling firm
- Cook Medical Incorporated
- Firm location
- Bloomington, IN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 18, 2025. FDA classified it 22 days later, on Oct 10, 2025. Distribution reported by FDA: 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 Cook Medical Incorporated has 10 recalls in our records.
Recalled products (1)
Z-0043-2026 Class I Ongoing
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
Codes / lots: ZTA2-P-40-117-W Box UDI-DI 10827002599151 Product UDI-DI 00827002599154 Lots E4626917 E4627437 E4627438 E4627439 E4627440 E4629948 E4629949 E4629950 E4629951 E4629952 E4629953 E4629954 E4629955 E4634911 E4634913 E4634915 E4634916 E4634917 E4646219 E4656519 E4656520 E4656521 E4659972 E4659973 E4659974 E4665450 E4679401 E4679406 E4683233 E4683236 E4683237 E4683238 E4684592 E4684593 E4701373 E4701375 E4701376 E4701377 E4701378 E4701379 E4701380 E4701402 E4704235; ZTA2-P-40-167 Box UDI-DI 10827002599205 Product UDI-DI 00827002599208 Lots E4715752 E4718032 E4718033 E4718034 E4718035; ZTA2-P-40-167-W Box UDI-DI 10827002599212 Product UDI-DI 00827002599215 Lots E4627442 E4627443 E4627444 E4627445 E4627446 E4627447 E4627448 E4627449 E4627450 E4627451 E4627452 E4631968 E4631969 E4631970 E4634918 E4634919 E4634920 E4635173 E4635174 E4646220 E4656525 E4656526 E4656527 E4656528 E4656529 E4659975…
Quantity: 695
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97615
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.