Zenith Flex G48461Recalls & 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 10827002484617), received between May 23, 2016 and May 23, 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
- Appropriate Device Problem Term/Code Not Available1
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 23, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE ILIAC LEG GRAFT (SAME SIDE AS BRANCH GRAFT) WAS NOT PATENT ON THE 4 YR-FOLLOW-UP CT IN THIS (B)(6) MALE PATIENT IN THE (B)(6) CLINICAL STUDY. ON (B)(6) 2012, THE PATIENT RECEIVED THE MULTIPLE DEVICES TO TREAT THE AAA. RANCH GRAFT: ZBIS-12-45-58 ; ZENITH AAA MAIN BODY: TFFB-30-96-ZT ; ILIAC LEG GRAFT (SAME SIDE AS BRANCH-LEFT): TFLE-16-56-ZT (SUBJECT OF THIS REPORT); ILIAC LEG GRAFT (OPPOSITE SIDE BRANCH-RIGHT): TFLE-24-73-ZT; CONNECT SX-80-10-40 ((B)(4)) MAIN BODY EXTENSION: ESBE (B)(4). THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE DEVICES. A MOLDING BALLOON WAS USED WITHOUT DIFFICULTY. POST STENT DILATATION WAS NOT PERFORMED. POST-PROCEDURE ANGIOGRAPHY REVEALED PATENT DEVICES WITH NO ENDOLEAKS OR KINKS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (ONE DAY POST PROCEDURE). FOLLOW-UP CTS: 1 MO: (B)(6) 2012 (24 DAYS POST PROCEDURE): DEVICES PATENT AND INTACT WITH NO KINKS, ENDOLEAK, OR COMPONENT SEPARATION. 6 MO: (B)(6) 2012 (237 DAYS POST PROCEDURE): DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR COMPONENT SEPARATION. AN UNKNOWN TYPE OF ENDOLEAK WAS NOTED. THROMBUS WAS NOTED WITHIN THE CONNECT STENT. 12 MO: (B)(6) 2013 (384 DAYS POST PROCEDURE): DEVICES P
Patient problems: No Code Available
MAUDE report 5673364 ↗
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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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