Ovation iX Iliac Stent Graft TV-IL1428120-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850007370190), received between May 6, 2024 and Sep 19, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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

Recent adverse event reports

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

• InjurySep 19, 2025Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO OVATION IX ILIAC LIMB EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 1B ENDOLEAK ON THE LEFT COMMON ILIAC ARTERY WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB TO SUCCESSFULLY RESOLVE THE TYPE 1B ENDOLEAK. THE PATIENT HAS BEEN DISCHARGED HOME. NOTE: THE INITIAL AND REINTERVENTION PROCEDURES ARE OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) AS THE SAFETY AND EFFECTIVENESS OF OTHER STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Clinical Endoleak

  MAUDE report 23096862 ↗
• InjuryAug 13, 2024Unintended Movement; Migration; Unintended Movement; Migration

  THE PATIENT UNDERWENT IMPLANTATION WITH AN ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023. DURING A FOLLOW-UP ON (B)(6) 2024, A SIGNIFICANT INCREASE IN THE ANEURYSM SAC SIZE AND A NON-DEVICE-RELATED TYPE 2 ENDOLEAK WERE IDENTIFIED. ADDITIONALLY, A 28MM OVATION LIMB WAS USED FOR THE RIGHT COMMON ILIAC ARTERY (CIA) LIMB, ALTHOUGH THE AVERAGE DIAMETER WAS ONLY 15MM. THIS SIZE MISMATCH CAUSED THE LIMB TO "MELON-SEED" INTO THE DISTAL AAA SAC, RESULTING IN A TYPE 1B ENDOLEAK. A NEW LIMB IS REQUIRED TO ADDRESS THIS ISSUE. ON (B)(6) 2024, THE PATIENT UNDERWENT A RE-INTERVENTION WHERE THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX EXTENDER AND AN OVATION IX ILIAC LIMB. THE FINAL PATIENT STATUS REMAINS UNKNOWN AND WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19975707 ↗
• InjuryMay 6, 2024Migration; Migration

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2024. DURING A ROUTINE FOLLOW-UP ON (B)(6) 2024, VIA COMPUTED TOMOGRAPHY (CT) SCAN, IT WAS NOTED THAT THE PATIENT'S LEFT ILIAC LIMB HAD MIGRATED DISTALLY FROM THE LEFT INTERNAL ARTERY, NEARING THE SAC. ON (B)(6) 2024, THE PATIENT UNDERWENT RE-INTERVENTION WITH THE IMPLANTATION OF AN ADDITIONAL OVATION IX ILIAC LIMB. THE LIMB WAS PLACED FROM THE MAIN BODY LIMB DOWN TO THE DISTAL COMMON ILIAC. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 19256228 ↗

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