Food, drugs, devices › Cook Medical Incorporated
Device recall: Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZT
FDA enforcement event 97615 is a device recall by Cook Medical Incorporated of Bloomington, IN, initiated 18 Sep 2025 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Cook Medical Incorporated has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cook Medical Incorporated, Bloomington, IN.
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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0043-2026 | 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… | 695 | Class I | Ongoing | 22 Oct 2025 |
Context
Other enforcement events for Cook Medical Incorporated
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Apr 2024 | EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 | Device | Class II | 2 |
| 14 Feb 2022 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65 | Device | Class III | 2 |
| 25 Feb 2019 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The G | Device | Class III | 6 |
| 25 Sep 2018 | Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stent | Device | Class II | 39 |
| 22 Mar 2017 | Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular | Device | Class I | 1 |
| 22 Dec 2015 | Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System | Device | Class II | 1 |
| 26 Sep 2014 | Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that con | Device | Class II | 1 |
All 8 events for Cook Medical Incorporated
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "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"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.