Zenith Flex G48452Recalls & reported problems
Cook Incorporated · Zenith Flex, AAA Endovascular Graft Iliac Leg · 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 10827002484525), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2022Difficult to Remove; Material Separation; Material Integrity Problem; Difficult to Remove; Material Separation; Material Integrity Problem
IT WAS REPORTED A (B)(6), MALE PATIENT REQUIRED A ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG FOR AN ENDOVASCULAR AORTIC REPAIR PROCEDURE. AFTER THE DELIVERY SYSTEM WAS ADVANCED TO THE AORTA AND THE GRAFT WAS RELEASED, THE USER OBSERVED UNDER X-RAY THAT THE TIP OF THE DELIVERY SYSTEM WAS STUCK TO THE FIRST STENT OF THE GRAFT. THE DOCTOR SUBSEQUENTLY REMOVED THE DELIVERY SYSTEM FROM THE PATIENT. HOWEVER, UPON REMOVAL THE TIP OF THE DELIVERY SYSTEM PULLED THE STENT MATERIAL OUT OF THE BODY. FOLLOWING ANGIOGRAPHY, THE DELIVERY SYSTEM WAS FOUND TO BE SHORTENED. A PHOTO PROVIDED BY THE USER SHOWED DAMAGE TO THE DELIVERY SYSTEM. ANOTHER LEG GRAFT WAS PLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446504 ↗
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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