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Ovation iX Iliac Stent Graft TV-IL1412160-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 00850007370411), received between Sep 9, 2022 and May 4, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Most reported problems

Device problems

  • Insufficient Device Problem Information2
  • Complete Blockage1
  • Lack of Effect1
  • Use of Device Problem1

Patient problems

  • Embolism/Embolus1
  • Ischemia1
  • Obstruction/Occlusion1
  • Stenosis1

Recent adverse event reports

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

  • InjuryMay 4, 2023Lack of Effect; Lack of Effect

    THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2023. THE 30 (THIRTY) DAY ROUTINE CONFIRMED BUTTOCK CLAUDICATION. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Patient problems: Ischemia

    MAUDE report 16872636 ↗
  • InjuryJan 4, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

    ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM AND AN OVATION IX EXTENDER IN THE LEFT LIMB. REPORTEDLY, PRIOR TO IMPLANT THE RIGHT INTERNAL ILIAC ARTERY WAS OCCLUDED. APPROXIMATELY ONE (1) MONTH POST-PROCEDURE, RIGHT LIMB STENOSIS WAS IDENTIFIED AT THE FOLLOW-UP. REINTERVENTION TOOK PLACE; HOWEVER, REINTERVENTION DETAILS WERE NOT PROVIDED. THE PATIENT STATUS POST-REINTERVENTION WAS NOT REPORTED.

    Patient problems: Stenosis

    MAUDE report 16098541 ↗
  • InjurySep 9, 2022Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

    THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP THE PATIENT WAS IDENTIFIED WITH THROMBOEMBOLISM IN THE RIGHT ILIAC LIMBS. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A GORE, VBX STENT GRAFT (NON-ENDOLOGIX).

    Patient problems: Embolism/Embolus; Obstruction/Occlusion

    MAUDE report 15394572 ↗

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

Other System, Endovascular Graft, Aortic Aneurysm Treatment devices

All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

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