COOK G47474Recalls & reported problems
William Cook Europe ApS · Zenith TX2, Dissection Endovascular Graft with Pro-form, and the Z-Trak Plus Introduction System-Tapered Component · Class 3 · Implant
All models of COOK (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002474748), received between Jul 2, 2019 and Jul 2, 2019 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Aneurysm1
- Death1
- Rupture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJul 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN ON (B)(6) 2019: "THE PHYSICIAN STRESSED THAT HE FELT THIS WAS NOT A DEVICE RELATED EVENT. THE THORACIC ANEURYSM/DISSECTION IN THIS PATIENT WAS QUITE LARGE AND COMPLEX TO BEGIN WITH AND THIS WAS A VERY CHALLENGING CASE AT BASELINE. THE LOCATION OF THE IMPLANTED STENT GRAFTS WAS ZONE 1 AFTER THE CAROTID-CAROTID-LSCA BYPASS. IT WAS VERY DIFFICULT TO DETERMINE THE ORIGINS OF THE PRIMARY DISSECTION FLAP. THE ANEURYSM WENT RETROGRADE AS WELL AS ANTEGRADE WITHIN THE ARCH".
Patient problems: Aneurysm; Death; Rupture
MAUDE report 8751840 ↗
Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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