Ovation iX Iliac Stent Graft TV-IL1414140-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850007370220), received between Aug 24, 2021 and Mar 3, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Calcified; Off-Label Use; Obstruction of Flow

  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. ROUTINE FOLLOW-UP ON APPROXIMATELY (B)(6) 2026 CONDUCTED A COMPUTED TOMOGRAPHY THAT IDENTIFIED THE LEFT OVATION IX LIMB WAS STENOSED. THE PATIENT WAS COMPLAINING OF LEFT HIP PAIN. THE PHYSICIAN BALLOONED THE LEFT OVATION IX LIMB, THEN IMPLANTED A (NON-ENDOLOGIX) BALLOON EXPANDABLE STENT TO TRY TO HELP OPEN UP THE STENOSIS. AFTER PLACING THE (NON-ENDOLOGIX) BALLOON EXPANDABLE STENT, THE PHYSICIAN CONDUCTED AN INTRAVASCULAR ULTRASOUND TO RE-EVALUATE. REPORTEDLY, IT WAS CONFIRMED THAT THE STENT GRAFT WAS STILL STENOSED AND WOULD NOT BE ABLE TO EXPAND TO ITS FULL DIAMETER DUE TO THE CALCIUM PREVENTING FULL STENT GRAFT PATENCY. REINTERVENTION WAS COMPLETED ON (B)(6) 2026 WHERE THE PHYSICIAN CHOSE TO CONVERT TO AN AORTO-UNI ILIAC (AUI) BY IMPLANTING AN ABBOTT (NON-ENDOLOGIX) AMPLATZER VASCULAR PLUG IN THE LEFT OVATION IX LIMB TO ACHIEVE OCCLUSION. THE PHYSICIAN THEN ELECTED TO IMPLANT A GORE (NON-ENDOLOGIX) VBX STENT IN THE RIGHT OVATION IX LIMB AND EXTENDED IT PROXIMALLY TO ESTABLISH A BETTER BLOOD FLOW. AFTER CONFIRMING STRONG BLOOD FLOW OF T

  Patient problems: Calcium Deposits/Calcification; Hematoma; Ischemia; Low Blood Pressure/ Hypotension; Myocardial Infarction; Pain; Stenosis

  MAUDE report 24503400 ↗
• InjuryDec 27, 2024Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY EIGHT (8) MONTHS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH LEG PAIN. THE LEFT LIMB WAS OCCLUDED FROM THE FLOW DIVIDER TO THE ALTO MAIN BODY TO THE END OF THE STENT; HOWEVER, THE HYPOGASTRIC AND THE EXTERNAL ILIAC ARTERIES ON THE LEFT ARE OPEN. THE PHYSICIAN ELECTED TO REVASCULARIZE THE LIMB AND IMPLANTED A NEW OVATION LIMB WITHIN THE OLD LIMB. A NON-ENDOLOGIX STENT WAS PLACED DISTAL TO THE OVATION LIMB TO OPEN A STENOSIS. THE FINAL ANGIOGRAM SHOWED THE STENT GRAFT IS OPEN AND THE PATIENT IS DOING WELL AND IS EXPECTED TO BE DISCHARGED HOME.

  Patient problems: Obstruction/Occlusion; Pain; Stenosis

  MAUDE report 21026301 ↗
• InjuryJul 24, 2024Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM ON (B)(6) 2022. ON (B)(6) 2024, IT WAS REPORTED THROUGH A CLINICAL STUDY THAT THE PATIENT PRESENTED WITH RIGHT HIP AND LEG CLAUDICATION AND WAS FOUND TO HAVE AN OCCLUSION OF THE RIGHT ILIAC ARTERY. THE PATIENT UNDERWENT RE-INTERVENTION, WHICH INCLUDED A RIGHT ILIAC THROMBECTOMY AND A FEMORAL-FEMORAL BYPASS. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 19817598 ↗
• InjuryMar 21, 2024Unintended Movement; Migration; Unintended Movement; Migration

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023, WITH THE IMPLANT OF AN ALTO ABDOMINAL AORTIC GRAFT SYSTEM. ENDOLOGIX WAS MADE AWARE ON (B)(6) 2024, THAT THE RIGHT LIMB WAS PULLED BACK SLIGHTLY. THERE WAS NO ENDOLEAK. REINTERVENTION WAS COMPLETED ON 08 MARCH 2024, WITH THE IMPLANT OF AN ADDITIONAL OVATION IX ILIAC LIMB TO EXTEND FURTHER INTO THE COMMON. FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952433 ↗
• InjuryDec 14, 2022Appropriate Device Problem Term/Code Not Available; Lack of Effect; Appropriate Device Problem Term/Code Not Available; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY SIX (6) DAYS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK TYPE 1B. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN OVATION IX ILIAC LIMB. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL POST-REPAIR.

  Patient problems: Clinical Endoleak; Failure of Implant; Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 15982935 ↗
• InjuryOct 3, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. ONE (1) DAY POST INITIAL PROCEDURE RIGHT LIMB THROMBOSIS WAS IDENTIFIED. THE PATIENT UNDERWENT FEM-FEM BYPASS. THE PATIENT TOLERATED THE PROCEDURE FINE. THE FINAL PATIENT STATUS WAS REPORTED TO BE DISCHARGED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15533264 ↗
• InjuryAug 24, 2021Complete Blockage; Deformation Due to Compressive Stress; Complete Blockage; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY EIGHT (8) DAYS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH LEG PAIN DUE TO A KINKED AND OCCLUDED RIGHT ILIAC LIMB. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY CANNULATING THE LIMB AND RE-INFORCING WITH A GORE(NON-ENDOLOGIX) VBX STENT GRAFT ON (B)(6) 2021. THE PATIENT IS REPORTEDLY IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 12360075 ↗

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