Ovation iX Iliac Stent Graft TV-IL1422100-JRecalls & reported problems

Endologix LLC · The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated. · Class 3 · Implant

All models of Ovation iX Iliac Stent Graft (66)

Data updated Oct 18, 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 00850007370329), received between May 28, 2025 and May 28, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Lack of Effect” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P120006); they may or may not involve this specific model.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Lack of Effect1

Patient problems

Clinical Endoleak1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 28, 2025Lack of Effect; Lack of Effect
THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2023. DURING A ROUTINE FOLLOW-UP ON (B)(6) 2025, THE PATIENT WAS REPORTED TO HAVE A POSSIBLE TYPE IB ENDOLEAK. THE PREVIOUS YEAR, THE PATIENT HAD BEEN IDENTIFIED WITH A TYPE II ENDOLEAK (ANATOMY-RELATED). THE PATIENT IS REPORTEDLY IN STABLE CONDITION AND IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.
Patient problems: Clinical Endoleak
MAUDE report 22096675 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120006. One submission often covers many models, so check the product and lot details in each record.

Z-2263-2020 · May 6, 2020 · Terminated
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
Z-0125-2015 · Sep 20, 2014 · Terminated
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device deliver
Z-0288-2013 · Oct 19, 2012 · Terminated
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The

Device details

UDI-DI	`00850007370329`
Brand	Ovation iX Iliac Stent Graft
Model	TV-IL1422100-J
Company	Endologix LLC
Product code	MIH · System, Endovascular Graft, Aortic Aneurysm Treatment
Class	Class 3
FDA submission	P120006
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Apr 7, 2026

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

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