Ovation iX Iliac Stent Graft TV-IL1422160-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850007370350), received between Mar 8, 2023 and Nov 21, 2025 — classified as 3 injuries.

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

• InjuryNov 21, 2025Migration; Lack of Effect; Migration; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM AND AN OVATION IX EXTENDER. THE PATIENT PRESENTED EMERGENTLY ON (B)(6) 2025 WITH ABDOMINAL PAIN AND A RUPTURED ANEURYSM. REPORTEDLY THE OVATION IX LIMB PULLED BACK INTO THE AORTA CAUSING A TYPE IB ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF ANOTHER OVATION IX LIMB TO EXTEND TO THE RIGHT HYPOGASTRIC. THE TYPE IB ENDOLEAK ON THE RIGHT SIDE WAS SEALED. THE PATIENTS ABDOMINAL PAIN SUBSIDED AND WAS SYMPTOM FREE. ONE WEEK LATER ON (B)(6) 2025 THE PATIENT WAS BROUGHT BACK IN TO COMPLETE AN EXTENSION ON THE LEFT COMMON ILIAC ARTERY (LCIA). THERE WAS NO ENDOLEAK PRESENT IN THE LCIA BEFORE THE PROCEDURE. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX LIMB TO EXTEND THE LCIA TO THE LEFT HYPOGASTRIC AS A PREVENTATIVE MEASURE. THE FINAL PATIENT STATUS WAS REPORTED TO BE WELL POST-SECONDARY PROCEDURES.

  Patient problems: Abdominal Pain; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 23618811 ↗
• InjuryMar 5, 2025Appropriate Device Problem Term/Code Not Available; 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 ON (B)(6) 2024. IT WAS REPORTED ON (B)(6) 2025, DURING A ROUTINE FOLLOW UP, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK. AN INTERVENTION IS PLANNED FOR (B)(6) 2025. THE PATIENT STATUS IS STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 21528170 ↗
• InjuryMar 8, 2023Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY THREE (3) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK, AN INCREASED ANEURYSM SAC (UNKNOWN DIAMETER) OF THE LEFT EXTERNAL ILIAC ARTERY (LEIA), A CONTAINED PSEUDOANEURYSM AND GRAFT INFECTION. THE PATIENT HAS BEEN ADMINISTERED ANTIBIOTICS. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY COILING THE INTERNAL ILIAC ARTERY AND EXTENDING THE ILIAC STENT INTO THE LEIA WITH TWO (2) ADDITIONAL OVATION IX ILIAC LIMBS ON 21 FEBRUARY 2023 (IN ORDER TO EXCLUDE THE PERSISTENT SCIATIC ARTERY). BLOOD CULTURES WERE ALSO REPEATED, AND PATIENT IS REPORTEDLY IN STABLE CONDITION. THE PHYSICIANS PLANS TO FURTHER TREAT BY CONVERTING PATIENT TO OPEN REPAIR WITH EXPLANTATION OF THE GRAFT, BUT THIS SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: Aneurysm; Clinical Endoleak; Pseudoaneurysm; Unspecified Infection

  MAUDE report 16503518 ↗

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