Zenith Spiral-Z G55240Recalls & reported problems

Cook Incorporated · Zenith, Spiral-Z AAA Iliac Leg · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002552408), received between Mar 11, 2016 and Jan 29, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Device problems

Fluid/Blood Leak1
Migration1
Occlusion Within Device1

Patient problems

Aneurysm1
No Code Available1
Rupture1
Thrombus1

Recent adverse event reports

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

InjuryJan 29, 2019Fluid/Blood Leak; Migration; Fluid/Blood Leak; Migration
IT WAS REPORTED THAT THE DEVICES MIGRATED DISTALLY TOGETHER AND CAUSED AN ENDOLEAK THAT LED TO A RUPTURED AORTIC ANEURYSM AT THE LEVEL OF THE INFERIOR MESENTERIC ARTERY (IMA). THE DEVICES WERE ORIGINALLY IMPLANTED AT A DIFFERENT HOSPITAL ON (B)(6) 2013. THE SURGEON COMPLETED AN OPEN JUXTARENAL ANEURYSM REPAIR. THE PATIENT IS CURRENTLY RECOVERING IN THE HOSPITAL. THE PATIENT DID ATTEND FOLLOW UP APPOINTMENTS AS RECENTLY AS (B)(6) 2018 WITH THE PHYSICIAN THAT INITIALLY IMPLANTED THE COMPLAINT DEVICES. THIS REPORT ADDRESSES THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-20-39-ZT, LOT 2793747) THAT MIGRATED DISTALLY. THE FOLLOWING REPORTS ARE RELATED IN REFERENCE AS THE TWO ADDITIONAL DEVICES WERE REPORTED TO MIGRATE DISTALLY AS WELL. 1820334-2019-00264 - TFFB-36-95, LOT 3902292; 1820334-2019-00265 - ZSLE-20-90-ZT, LOT 3819572.
Patient problems: Aneurysm; No Code Available; Rupture
MAUDE report 8286462 ↗
InjuryMar 11, 2016Occlusion Within Device; Occlusion Within Device
A (B)(6) YEAR OLD MALE PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR. POST EVAR, THE PATIENT HAD A RIGHT LIMB OCCLUSION. PATIENT HAD TO HAVE ADJUNCTIVE PROCEDURES TO UNBLOCK THE OCCLUSION.
Patient problems: Thrombus
MAUDE report 5495247 ↗

Device details

UDI-DI	`10827002552408`
Brand	Zenith Spiral-Z
Model	G55240
Catalog no.	ZSLE-20-39-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.

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

Endurant® IIs ESBF2814C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls34 deaths254 reports
Endurant® IIs ESBF3214C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls19 deaths173 reports
Endurant® IIs ESBF3614C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
1 recall37 deaths214 reports
Endurant® IIs ESBF2514C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls18 deaths136 reports
Endurant® IIs ESBF2314C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls9 deaths60 reports
RelayPro Thoracic Stent-Graft System 28-N4-34-154-34U
Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
3 recalls7 reports
Vela Proximal Endograft System A34-34/C100-O20 V
Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
3 deaths152 reports
Endurant® II ETCF2828C49E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls7 deaths44 reports

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page