Ovation iX Iliac Stent Graft TV-IL1418120-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850007370299), received between Dec 20, 2022 and Dec 13, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Lack of Effect” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2023Migration; Lack of Effect; Migration; Lack of Effect

  THE PATIENT WAS TREATED FOR A LARGE ABDOMINAL AORTIC ANEURYSM WITH A RIGHT COMMON ILIAC ANEURYSM ON (B)(6) 2023 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM, AND AN ADDITIONAL OVATION IX ILIAC LIMB IN BOTH THE RIGHT AND LEFT ILIACS. IT WAS REPORTED ON (B)(6)2023, THAT A ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A TYPE IB ENDOLEAK OF THE LEFT COMMON ILIAC ARTERY. REINTERVENTION IS IN THE PIPELINE FOR (B)(6) 2023.

  Patient problems: Clinical Endoleak

  MAUDE report 18323537 ↗
• InjuryDec 20, 2022Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM. REPORTEDLY, DURING DEPLOYMENT, THE ALTO AORTIC BODY TWISTED. APPROXIMATELY TWO (2) MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM. IT WAS IDENTIFIED THAT THE ILIAC LIMB OF THE ALTO AORTIC STENT GRAFT WAS THROMBOSED. LYTICS WERE INTRAVENOUSLY ADMINISTERED, AND THE OCCLUSION IN THE LIMB WAS STENTED (NON-ENDOLOGIX) SUCCESSFULLY RESTORING THE FLOW. THE PATIENT WAS IN GOOD CONDITION POST-REINTERVENTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16017796 ↗

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