Ovation iX Iliac Stent Graft TV-IL1414120-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: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850007370213), received between Apr 18, 2024 and Mar 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).

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

Obstruction of Flow2
Deformation Due to Compressive Stress1
Difficult to Advance1
Lack of Effect1
Patient-Device Incompatibility1

Patient problems

Obstruction/Occlusion2
Clinical Endoleak1
Pain1
Stenosis1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryMar 18, 2025Obstruction of Flow; Deformation Due to Compressive Stress; Difficult to Advance; Obstruction of Flow; Deformation Due to Compressive Stress; Difficult to Advance
THE PATIENT WAS INITIALLY TREATED WITH AN ALTO STENT GRAFT SYSTEM FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. THE DELIVERY SYSTEM WAS INSERTED THROUGH THE RIGHT APPROACH, AND THE ALTO MAIN BODY WAS IMPLANTED. THE POLYMER WAS FILLED WITHOUT PROBLEMS. THE CONTRALATERAL GATE CANNULATION WAS PERFORMED THROUGH THE CROSSOVER LUMEN; HOWEVER, RESISTANCE WAS ENCOUNTERED DUE TO STENOSIS IN THE ILIAC LIMB. BOTH LEFT AND RIGHT ILIAC LIMBS WERE IMPLANTED, AND THE PROCEDURE WAS COMPLETED. POST INITIAL PROCEDURE, THERE WAS OCCLUSION IN THE LEFT AND RIGHT LIMBS. THE PHYSICIAN ELECTED TO IMPLANT A GORE EXCLUDER (NON ENDOLOGIX) LIMB ON (B)(6) 2025 TO RESOLVE THIS EVENT. THE PATIENT STATUS WAS NOT REPORTED.
Patient problems: Obstruction/Occlusion
MAUDE report 21632952 ↗
InjuryJun 11, 2024Obstruction of Flow; Obstruction of Flow
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANTATION OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. THE PATIENT LATER EXPERIENCED LEG PAIN DUE TO LIMB OCCLUSION. ON (B)(6) 2024, THE PATIENT UNDERWENT A RE-INTERVENTION DURING WHICH BALLOONING IMPROVED BLOOD FLOW. DUE TO SIGNIFICANT THROMBI IN THE LIMB STENT GRAFT, A (NON-ENDOLOGIX) VBX DEVICE AND E-LUMINEXX (NON-ENDOLOGIX) DEVICES WERE ADDED TO THE RIGHT SIDE AND BOTH JUNCTIONS. AFTER ADDITIONAL BALLOONING, THE FINAL ANGIOGRAPHY SHOWED NO ISSUES. A TYPE II ENDOLEAK (NON-DEVICE RELATED FAILURE) WAS OBSERVED POST-PROCEDURE.
Patient problems: Obstruction/Occlusion; Pain; Stenosis
MAUDE report 19515368 ↗
InjuryApr 18, 2024Patient-Device Incompatibility; Lack of Effect; Patient-Device Incompatibility; Lack of Effect
THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023. DURING ROUTINE FOLLOW UP THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK. IT WAS REPORTED THAT THE RIGHT HYPOGASTRIC ARTERY WAS PREVIOUSLY EMBOLIZED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) OVATION IX ILIAC LIMB ON (B)(6) 2024 TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST THE SECONDARY PROCEDURE.
Patient problems: Clinical Endoleak
MAUDE report 19137786 ↗

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	`00850007370213`
Brand	Ovation iX Iliac Stent Graft
Model	TV-IL1414120-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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