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Ovation iX Iliac Stent Graft TV-EX282845-JRecalls & reported problems

Endologix LLC · The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions 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 00850007370077), received between Jul 20, 2022 and Jul 20, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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.

Most reported problems

Device problems

  • Off-Label Use1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryJul 20, 2022Off-Label Use; Off-Label Use

    THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (OFF -LABEL PROCEDURE DUE TO THE USE OF AFX WITH OVATION DEVICES). APPROXIMATELY 4 MONTHS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. REPORTEDLY, THE PATIENT HAS COVID AND THERE IS NO SCHEDULE DATE FOR RE-INTERVENTION YET.

    Patient problems: Failure of Implant

    MAUDE report 15070781 ↗

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

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