Zenith Flex G42787Recalls & reported problems
Cook Incorporated · Zenith Flex, AAA 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 10827002427874), received between Jun 28, 2016 and Jun 28, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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
- 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.
InjuryJun 28, 2016Leak/Splash; Leak/Splash
ON (B)(6) 2016, A (B)(6) MALE PATIENT UNDERWENT EVAR FOR AAA (FUSIFORM TYPE). THE PATIENT WAS JUDGED TO BE ANATOMICALLY SUITABLE FOR THE PROCEDURE DESPITE LOCALIZED STENOSIS IN BOTH RIGHT AND LEFT ACCESS ROUTES. PROCEDURE WAS PLANNED AS FOLLOWS; PLACING MAINBODY (ANOTHER MANUFACTURER) FIRST, THEN PLACING 30MM X 58MM EXTENSION STENT GRAFT (ESBE) ABOVE THE MAINBODY DUE TO A DIFFERENCE IN THE NECK DIAMETER. THE REASON WHY THE USER CHOSE COOK'S BODY EXTENSION DESPITE USING ANOTHER MANUFACTURER'S MAINBODY WAS THAT THERE WAS NO 30MM EXTENSION STENT GRAFT AVAILABLE FROM THE OTHER MANUFACTURER. THE MAIN BODY (ANOTHER MANUFACTURER) WAS SUCCESSFULLY PLACED, SO THE DELIVERY SYSTEM OF THE ESBE WAS ADVANCED BY RIGHT APPROACH. HOWEVER, THE DELIVERY SYSTEM COULD NOT PASS THROUGH THE STENOSED SITE IN THE RIGHT EIA. TORQUE WAS APPLIED TO THE DEVICE THOUGH, IT WOULD NOT ADVANCE. THE USER THOUGHT THAT THE STENOSED SITE IN THE EIA CONTRIBUTED TO THE ADVANCEMENT FAILURE, SO DILATION WAS PERFORMED IN THE SITE WITH 8MM PTA BALLOON. AFTER THAT, THE DELIVERY SYSTEM OF ESBE- WAS ADVANCED AGAIN, BUT IT FAILED. THE USER DECIDED TO STOP USING THE DEVICE CONSIDERING RISK OF DAMAGING THE VESSEL. THEN, ADDITIONAL
Patient problems: No Code Available
MAUDE report 5755764 ↗
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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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