Zenith Flex G55214Recalls & reported problems
Cook Incorporated · Zenith Flex, AAA Endovascular Graft Main Body Extension · 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
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002552149), received between May 7, 2020 and May 7, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN (B)(6) YEAR-OLD MALE PATIENT DEVELOPED A TYPE IV ENDOLEAK FOLLOWING IMPLANTATION OF A ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION. THE PATIENT ORIGINALLY HAD A MAIN BODY AND TWO LIMBS IMPLANTED PRIOR TO (B)(6) 2017 (WHICH IS REPORTED UNDER MDR REFERENCE # 1820334-2020-00921). IN (B)(6) 2017, THE PATIENT RECEIVED A ZENITH LOW PROFILE MAIN BODY EXTENSION IN A STAND-ALONE PROCEDURE. ON (B)(6) 2019, THE PATIENT RECEIVED A ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION (THE SUBJECT OF THIS REPORT) AS WELL AS THREE ZISL LEG GRAFTS. FOLLOWING IMPLANTATION OF ALL DEVICES, THE PATIENT'S ANEURYSMAL SAC WAS FOUND TO STILL BE ENLARGING (AS SEEN IN A CT/ULTRASOUND FOLLOW-UP), SO THE ENTIRE GRAFT WAS RELINED ON (B)(6) 2020. THE ATTENDING REP BELIEVES THAT "THE PATIENT HAD A CONTAINED RUPTURE" THAT WAS TREATED. IT IS CURRENTLY UNKNOWN AS TO WHICH GRAFT(S) CONTRIBUTED TO THE TYPE IV ENDOLEAK. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Code Available
MAUDE report 10033577 ↗
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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