Ovation iX Iliac Stent Graft TV-IL1414160-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850007370435), received between Jan 3, 2023 and Sep 28, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• InjurySep 28, 2023Off-Label Use; Deformation Due to Compressive Stress; Off-Label Use; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY EIGHT (8) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A KINK ON THE RIGHT ILIAC LIMB AND A TIGHT AREA (CLASSIFIED AS STENOSIS) BELOW THE SEALING RINGS OF THE MAIN BODY; THESE WERE IDENTIFIED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN PLANS TO RE-INTERVENE, BUT SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: Stenosis

  MAUDE report 17839634 ↗
• InjuryFeb 7, 2023Device Stenosis; Device Stenosis

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A "HEMODYNAMICALLY SIGNIFICANT STENOSIS OF [THE] RIGHT EXTERNAL ILIAC LIMB EXTENSION". THE DIAGNOSING PHYSICIAN INDICATED, "IT IS CLINICALLY IRRELEVANT AS THE PATIENT HAS A STRONG FEMORAL PULSE AND NO CLAUDICATION SYMPTOMS. NO INTERVENTION DEEMED NECESSARY AT THIS TIME, PLAN IS TO MONITOR." NOTE: THIS IS A CLINICAL STUDY PATIENT.

  Patient problems: Stenosis

  MAUDE report 16310658 ↗
• InjuryJan 3, 2023Obstruction of Flow; Deformation Due to Compressive Stress; Device-Device Incompatibility; Obstruction of Flow; Deformation Due to Compressive Stress; Device-Device Incompatibility

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE OVATION IX LEFT ILIAC LIMB WAS FOUND TO BE OCCLUDED; HOWEVER, THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AND NO INTERVENTION IS PLANNED AT THIS TIME.

  Patient problems: Clinical Endoleak; Failure of Implant; Obstruction/Occlusion

  MAUDE report 16091571 ↗

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