Ovation iX Iliac Stent Graft TV-IL1428160-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850007370008), received between Jun 15, 2022 and Nov 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryNov 18, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW-UP, THE COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED ANEURYSM ENLARGEMENT AND A TYPE 1B ON ENDOLEAK COMING FROM THE LEFT ILIAC ARTERY WITH NO SEAL FROM THE FLARED OVATION IX ILIAC LIMB. THE PHYSICIAN ELECTED TO COIL THE PATIENT'S LEFT INTERNAL ILIAC ARTERY WITH (NON-ENDOLOGIX) COILS AND IMPLANT TWO (2) OVATION IX ILIAC EXTENSIONS FROM THE AORTIC BODY LIMB DOWN INTO THE LEFT EXTERNAL ILIAC ARTERY TO CREATE A SEAL TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST THIS SECONDARY PROCEDURE AND WAS DISCHARGED HOME THE NEXT DAY.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23583390 ↗
• InjuryJun 15, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO ABDOMINAL STENT GRAFT SYSTEM (ONE (1) ALTO MAIL BODY AND TWO (2) OVATION IX ILIAC LIMBS). AN INTRAOPERATIVE TYPE 1B ENDOLEAK OCCURRED DUE TO THE CLOSURE DEVICE MOVING THE OVATION IX LIMB. THE FOLLOWING DAY THE PHYSICIAN ELECTED TO DO A RE-INTERVENTION AND ELECTED TO IMPLANTED AN OVATION IX EXTENDER AND OVATION IX ILIAC LIMB TO RESOLVED THE TYPE 1B ENDOLEAK. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 14699595 ↗

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