Zenith Flex G48465Recalls & 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: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002484655), received between Apr 29, 2020 and Jan 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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

Activation Problem1
Failure to Advance1

Patient problems

No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionJan 13, 2022Failure to Advance; Failure to Advance
IT WAS REPORTED THAT A GAP WAS FOUND BETWEEN THE ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG TIP AND THE SHEATH, LEADING TO A FAILED DEPLOYMENT OF THE GRAFT. DURING AN ENDOVASCULAR EXCLUSION OF AN ABDOMINAL AORTIC ANEURYSM, A GAP WAS NOTED BETWEEN THE GRAFT TIP AND THE SHEATH AS THE OPERATOR OPENED THE DEVICE. AN ATTEMPT TO CONTINUE THE PROCEDURE WAS MADE, HOWEVER RESISTANCE CAUSED BY THE GAP PREVENTED THE GRAFT FROM ADVANCING TO THE TARGET SITE. SEVERAL ATTEMPTS WERE MADE, BUT ALL FAILED. THE DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW LIKE DEVICE. IT WAS CONFIRMED BY THE CUSTOMER THAT THE COMPLAINT GRAFT WAS NOT UNSHEATHED DURING THE PROCEDURE. NO HARM TO THE PATIENT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13251011 ↗
MalfunctionApr 29, 2020Activation Problem; Activation Problem
ON (B)(6) 2020, THE SALES REPRESENTATIVE WHO WAS PRESENT AT THE PROCEDURE CONFIRMED THAT THE EVENT OCCURRED DURING THE PREPARATION STAGE. THE OPERATOR TRIED TO PULL OUT THE SHIPPING STYLET AND FOUND THE STYLET WAS UNABLE TO BE PULLED OUT, AND THE SHEATH WAS ALSO TWISTED DUE TO THE FORCE. THE PROCEDURE WAS FINALLY COMPLETED WITH ANOTHER NEW DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10010953 ↗

Device details

UDI-DI	`10827002484655`
Brand	Zenith Flex
Model	G48465
Catalog no.	TFLE-18-56-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	Not 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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