Ovation iX Iliac Stent Graft TV-IL1422140-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850007370343), received between Dec 16, 2021 and Dec 26, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Off-Label Use” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2024Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021, WITH THE IMPLANTATION OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. ON (B)(6) 2024, THE PATIENT UNDERWENT A REINTERVENTION TO ADDRESS A LOST SEAL IN A DILATED RIGHT COMMON ILIAC ARTERY. THE PROCEDURE INVOLVED COILING THE RIGHT HYPOGASTRIC ARTERY AND EXTENDING A 14 MM DIAMETER OVATION LIMB INTO THE EXTERNAL ILIAC ARTERY. THE OPERATION WAS SUCCESSFUL, AND THE PATIENT IS EXPECTED TO BE DISCHARGED THE FOLLOWING MORNING.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21020036 ↗
• InjuryMay 19, 2023Off-Label Use; Unintended Movement; Off-Label Use; Unintended Movement

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY EIGHT (8) DAYS POST INITIAL PROCEDURE, THE PATIENT PRESENTED IN THE OPERATING ROOM AND THE LEFT OVATION IX ILIAC LIMB WAS FOUND TO HAVE PULLED INTO THE ANEURYSM SAC. A TYPE 1B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT A 14X160MM OVATION LIMB IN THE LEFT ILIAC EXTENDING TO THE LEFT EXTERNAL ILIAC ARTERY, 4CM PAST THE LEFT HYPOGASTRIC ARTERY TO SEAL THE ANEURYSM AND ILIACS AND RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: Clinical Endoleak

  MAUDE report 16970420 ↗
• InjuryApr 7, 2022Migration or Expulsion of Device; Off-Label Use; Insufficient Device Problem Information; Migration or Expulsion of Device; Off-Label Use; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENLARGED COMMON ILIAC ARTERY (UNKNOWN DIAMETER) BUT NO VISIBLE ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE, AND PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm

  MAUDE report 14047801 ↗
• InjuryDec 16, 2021Migration; Migration

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE AND A HALF (1.5) MONTHS POST INITIAL PROCEDURE ONE OF THE OVATION LIMBS WAS FOUND TO HAVE MIGRATED PROXIMALLY AND RESULTED IN A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO COIL THE RIGHT HYPOGASTRIC ARTERY AND EXTENDED WITH TWO (2) OVATION IX ILIAC LIMBS, A 14X160 AND A 14X120 TO RESOLVE THIS EVENT. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 13019506 ↗

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