Zenith Flex G32179Recalls & 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 10827002321790), received between Apr 10, 2015 and Apr 10, 2015 — classified as 1 injury.
The most frequently reported specific device problem is “Dissection” (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
- Dissection1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2015Dissection
AN (B)(6) FEMALE PATIENT UNDERWENT AAA REPAIR BY RIGHT FEMORAL APPROACH. THE PATIENT WAS SUITABLE FOR ENDOVASCULAR REPAIR; SACCULAR ANEURYSM OF THE ABDOMINAL AORTA, NO TORTUOSITY, ENOUGH LENGTH OF PROXIMAL AND DISTAL NECK. BOTH CIA IS SHORT, HOWEVER, IT WAS SECURED 30 MM FOR BOTH SIDES. AFTER PLACING THE MAINBODY (TFFB-22-96-ZT) AND ILIAC LEGS, PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY (1820334-2015-00210). THE PHYSICIAN PLANNED TO ADD THE EXTENSION (ESBE-26-39) IN THE PROXIMAL NECK OF THE MAIN BODY, AND WHEN HE ATTEMPTED TO ADVANCE THE EXTENSION FROM RIGHT, HE FELT RESISTANCE. THEREFORE, HE REMOVED THE DEVICE FROM THE PATIENT'S BODY AND OBSERVED THE ENDOSPORIUM BETWEEN THE DILATOR TIP AND SHEATH. HE DETERMINED NOT TO ATTEMPT THE DEVICE FROM RIGHT SIDE BECAUSE OF THE RISK AND ADVANCED THE DEVICE FROM LEFT THIS TIME; HOWEVER, HE FELT RESISTANCE AGAIN.
Patient problems: Vascular Dissection
MAUDE report 4690268 ↗
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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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