Zenith Flex G31174Recalls & reported problems
Cook Incorporated · Zenith Flex, AAA Main Body Graft · Class 3 · Implant
All models of Zenith Flex (54)
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 10827002311746), received between Dec 14, 2018 and Dec 14, 2018 — classified as 1 death.
The most frequently reported specific device problem is “Migration” (1 report).
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
- Migration1
Patient problems
- Aortic Dissection1
- Death1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 14, 2018Migration; Migration
ADDITIONAL INFORMATION PROVIDED ON 28JAN2019 THAT CLARIFIED THE EVENT DESCRIPTION WITH THE FOLLOWING INFORMATION. THE PATIENT WAS IMPLANTED WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY ON (B)(6) 2018 AT (B)(6) HOSPITAL WITH NO DIFFICULTY OR ADVERSE EVENTS REPORTED. THE PATIENT CHOSE TO DO THE FOLLOW-UP EXAMINATION ONE MONTH AFTER IMPLANTATION AT ANOTHER FACILITY, (B)(6) HOSPITAL. IT WAS REPORTED, THE PATIENT FELT CHEST AND BACK PAIN ONE-MONTH AFTER IMPLANTATION OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. THERE WAS A NEW DISSECTION OF AORTA FOUND AT PROXIMAL END OF GRAFT UPWARD TOWARD THE AORTIC ARCH. THE INITIAL COMPLAINT NOTIFICATION ALSO STATED THAT THE GRAFT MOVED AFTER IMPLANTATION. DESPITE OUR ATTEMPTS TO GAIN ADDITIONAL INFORMATION, (B)(6) HOSPITAL DID NOT SHARE MORE INFORMATION REGARDING THE FOLLOW UP EXAMINATION, ADDITIONAL PROCEDURES, OR THE PATIENT¿S DEATH.
Patient problems: Aortic Dissection; Death; Pain
MAUDE report 8164798 ↗
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- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
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- 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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