Ovation iX Iliac Stent Graft TV-IL1418100-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850007370282), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 injury.

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

• InjuryApr 17, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2022 WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. AFTER EMBOLIZATION OF THE LUMBAR AND INTERNAL ILIAC ARTERIES, THE ALTO MAIN BODY WAS DEPLOYED ALIGNED WITH THE RIGHT RENAL ARTERY. AFTER POLYMER FILLING, THE CONTRALATERAL LEG WAS DEPLOYED. FOURTEEN MINUTES AFTER DEPLOYMENT, THE INTERNAL BALLOON WAS EXPANDED, AND ANGIOGRAPHY CONFIRMED THE ABSENCE OF A TYPE I ENDOLEAK. THE IPSILATERAL LEG WAS DEPLOYED, AND AFTER TOUCH-UP, ANGIOGRAPHY CONFIRMED THE ABSENCE OF AN ENDOLEAK, AND THE PROCEDURE WAS COMPLETED. NO ANEURYSM DIAMETER ENLARGEMENT WAS OBSERVED UNTIL THE 1-YEAR FOLLOW-UP. ON THE 2-YEAR FOLLOW-UP ON (B)(6) 2024, AN ANEURYSM DIAMETER ENLARGEMENT OF 5 MM OR MORE WAS OBSERVED. THE TYPE OF ENDOLEAK WAS UNKNOWN, UNTIL IDENTIFIED AS A TYPE IB ENDOLEAK DURING REINTERVENTION WHICH WAS COMPLETED ON (B)(6) 2025. THE PHYSICIAN ELECTED TO IMPLANT A GORE (NON-ENDOLOGIX) EXCLUDER ILIAC BRANCH ENDOPROSTHESIS TO RESOLVE THIS EVENT. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21862181 ↗

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