Zenith Flex G55215Recalls & reported problems

Cook Incorporated · Zenith Flex, AAA Endovascular Graft 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: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002552156), received between May 7, 2021 and Dec 28, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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

Failure to Advance1
Material Twisted/Bent1
Migration1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 28, 2021Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent
IT WAS REPORTED THAT A ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION WAS DIFFICULT TO ADVANCE DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. DURING THE PROCEDURE, THE HYDROPHILIC COATING WAS ACTIVATED AND THE DELIVERY SYSTEM WAS ROTATED TOGETHER AS PER THE IFU. LIMB OCCLUSION WAS NOTED WHEN THE ACCESS VESSELS WERE EXPOSED. UPON ADVANCEMENT OF THE DEVICE, DIFFICULTY WAS ENCOUNTERED. THE PHYSICIAN WAS UNABLE TO PLACE THE DEVICE IN THE INTENDED TARGET ZONE. IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS BENT. A COMPETITOR'S DEVICE WAS PLACED AND THE ENDOLEAK WAS RESOLVED. IT WAS NOTED THAT OPERATIVE TIME WAS EXTENDED DUE TO THIS OCCURRENCE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. OTHER EVENTS REGARDING THIS PATIENT ARE ALSO REPORTED UNDER PATIENT IDENTIFIER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13101431 ↗
InjuryMay 7, 2021Migration; Migration
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11793662 ↗

Device details

UDI-DI	`10827002552156`
Brand	Zenith Flex
Model	G55215
Catalog no.	ESBE-30-58-ZT
Company	Cook Incorporated
Product code	MIH · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Sep 24, 2025

Device type (GMDN): Aortoiliac endovascular stent-graft

A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.

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All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

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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