Zenith Flex G48404Recalls & reported problems
Cook Incorporated · Zenith Flex, AAA Endovascular Graft Main Body · 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 10827002484044), received between May 9, 2018 and May 9, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Hole In Material” (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
- Hole In Material1
- Leak/Splash1
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 9, 2018Hole In Material; Leak/Splash; Hole In Material; Leak/Splash
ON (B)(6) 2015, A FEMALE PATIENT HAD UNDERGONE ENDOVASCULAR ANEURYSM REPAIR (EVAR) BY RIGHT APPROACH FROM THE FEMORAL ARTERY (FA). THE PATIENT WAS SUITABLE FOR THE PROCEDURE. ON (B)(6) 2018, A FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT) SCAN CONFIRMED ANEURYSM ENLARGEMENT FROM 65 MM TO 70 MM. A CAUSE OF THE ANEURYSM ENLARGEMENT COULD NOT BE DETERMINED, ABDOMINAL SURGERY WAS PERFORMED ON (B)(6) 2018. THE SURGERY CONFIRMED BLOOD LEAKING FROM MULTIPLE SUTURE HOLES OF THE MAIN BODY. THE LEAKING POINTS WERE MENDED BY APPLYING MEDICAL ADHESIVE AND BANDING. THE PATIENT RECOVERED BY (B)(6) 2018.
Patient problems: No Code Available
MAUDE report 7498323 ↗
Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices
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- 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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