Zenith Flex G48456Recalls & 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 10827002484563), received between Sep 28, 2016 and Sep 28, 2016 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2011 THAT THREE STENT GRAFTS WERE IMPLANTED IN THE PATIENT WITH NO REPORTED ISSUES. IN (B)(6) 2016 ENLARGEMENT OF THE ANEURYSM WAS CONFIRMED BY COMPUTED TOMOGRAPHY (CT); HOWEVER, IT COULD NOT BE DETERMINED IF THERE WAS AN ENDOLEAK. AN ANGIOGRAPHY WAS PERFORMED ON AN UNKNOWN DATE IN AUGUST 2016; WHICH WAS UNABLE TO CONFIRM THE EXISTENCE OR NON-EXISTENCE OF AN ENDOLEAK. THE SALES REPRESENTATIVE HAS BEEN ASKED TO CONFIRM THE ABOVE INFORMATION DURING A VISIT TO THE SITE. THE PHYSICIAN REPORTEDLY COMMENTED THERE IS SUSPICION OF "TYPE IV ENDOLEAK OR TYPE III (PINHOLE) ENDOLEAK. IMPLANTATION OF EXCLUDER LEG INSIDE OF THE FLEX IS UNDER CONSIDERATION." NONE OF THE INFORMATION HAS BEEN CONFIRMED AS OF THE DATE OF THIS REPORT AND NO OTHER INFORMATION IS CURRENTLY AVAILABLE. REPORTEDLY IMAGES ARE AVAILABLE FOR FURTHER REVIEW.
Patient problems: Aneurysm
MAUDE report 5983136 ↗
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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