Ovation iX Iliac Stent Graft TV-IL1410100-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850007370121), received between Jul 14, 2022 and Apr 30, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Complete Blockage; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR A SMALL ABDOMINAL AORTIC ANEURYSM (AAA) AND THROMBOTIC AORTA ON (B)(6) 2026 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL STENT GRAFT AND AN OVATION IX ILIAC LIMB STENT GRAFT. THE PATIENT PRESENTED EMERGENTLY ON (B)(6) 2026 WITH A COLD LEFT LEG DUE TO LEFT ILIAC LIMB OCCLUSION WHERE THE AFX2 BSG LEG AND THE OVATION IX LIMB STENT GRAFT OVERLAPPED. IT WAS REPORTED THAT THE PHYSICIAN OBSERVED AN ACUTE BEND. REINTERVENTION WAS COMPLETED ON (B)(6) 2026. THE PHYSICIAN ELECTED TO PERFORM A PENUMBRA (NON-ENDOLOGIX) THROMBECTOMY AND THEN RE-LINED THE AREA WITH A GORE (NON-ENDOLOGIX) VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS. NORMAL STENT GRAFT PATENCY WAS RESTORED TO THE LIMB AND PATIENT WAS DOING WELL. THE FINAL PATIENT STATUS WAS REPORTED TO BE STABLE POST-SECONDARY PROCEDURE. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 25049061 ↗
• InjuryJun 16, 2025Off-Label Use; Off-Label Use

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. REPORTEDLY THE PATIENT HAD EXTENSIVE BI-LATERAL ILIAC DISEASE AS WELL WITH CALCIUM OCCLUSION. AN OVATION IX LIMB WAS PLACED ON THE RIGHT-SIDE POST AAA REPAIR AND THE EXTERNAL ILIAC WAS RUPTURED. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. THE SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN REPAIR IN ORDER TO FIX THE DISTAL EXTERNAL INTO THE FEMORAL WITH A GRAFT/PATCH REPAIR. PATIENT STATUS WAS STABLE AND CLOSED. APPROXIMATELY 1 HOUR LATER BEFORE LEAVING THE OPERATING ROOM THE PATIENT BECAME UNSTABLE, AND PRESSURE DROPPED. THE SURGEON RE-OPENED THE PATIENT INCISION TO INVESTIGATE AND SAW AN ILIAC TEAR HIGHER UP THAT REQUIRED ADDITIONAL OVATION IX LIMBS OVERLAPPING INTO THE AFX2 MAIN BODY LIMB. THIS COVERED THE ILIAC TEAR AND THE PATIENT WAS STABILIZED. THE FINAL PATIENT STATUS WAS REPORTEDLY STABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels; Ruptured Aneurysm

  MAUDE report 22213705 ↗
• InjuryOct 7, 2024Device Stenosis; Device Stenosis

  THE PATIENT PRESENTED EMERGENTLY ON (B)(6) 2024, WITH A COLD LEG AND AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE PATIENT WAS NOT TAKING THEIR BLOOD THINNERS. THE PATIENT WAS TREATED FOR THE AAA WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS NOTED THAT THERE WAS SIGNIFICANT EXTERNAL ILIAC STENOSIS AND THE PHYSICIAN TREATED THIS WITH THE IMPLANT OF A NON-ENDOLOGIX BALLOON EXPANDABLE STENT AND SUBSEQUENTLY THE ARTERY PERFORATED. THIS CAUSE THE PATIENT TO CODE. AN ADDITIONAL OVATION IX ILIAC LIMB (10X100MM) WAS IMPLANTED. THE PERFORATION WAS COVERED AND BLOOD PRESSURE RETURNED TO NORMAL. THE PHYSICIAN REPORTED ON 26 SEPTEMBER 2024, THAT THE GRAFT HAS THROMBOSED AND THE PATIENT IS BEING MONITORED; HOWEVER, IS EXPECTED TO EXPIRE.

  Patient problems: Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 20385536 ↗
• InjuryApr 19, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE PATIENT HAD VERY TORTUOUS ANATOMY WITH LARGE AAA AND THE COMMON WAS VERY SHORT. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE, IT WAS IDENTIFIED THAT THE LEFT LIMB HAD PULLED BACK INTO THE AAA SAC AND THERE WAS A TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL OVATION IX ILIAC LIMBS. THE INTERVENTION WAS COMPLETED, AND THE PATIENT IS REPORTED AS DOING FINE.

  Patient problems: Clinical Endoleak

  MAUDE report 19142301 ↗
• InjuryJul 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE ALTO ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1 MONTH POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK AT THE JUNCTION OF THE LIMBS WAS IDENTIFIED. THE PATIENT'S CURRENT STATUS WAS NOT REPORTED AND A REINTERVENTION HAS NOT BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 15016049 ↗

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