Ovation iX Iliac Stent Graft TV-IL1418160-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850007370374), received between Jul 12, 2023 and Mar 30, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ALTO MAIN BODY AND TWO (2) OVATION IX ILIAC LIMBS. APPROXIMATELY FOUR (4) MONTHS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH ABDOMINAL PAIN. AFTER AN ANGIOGRAM, A TYPE 1B ENDOLEAK WAS IDENTIFIED AS WELL AS BOTH ILIAC LIMBS HAD MIGRATED BACK INTO THE ABDOMINAL ANEURYSM. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO IMPLANT ONE (1) ADDITIONAL OVATION IX LIMB IN EACH ILIAC. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 3008011247-2021-00126.NOW, APPROXIMATELY FOUR AND HALF (4.5) YEARS POST THE SECONDARY REINTERVENTION PROCEDURE, A TYPE 1B ENDOLEAK WAS IDENTIFIED. THE RIGHT ILIAC LIMB APPEARS TO HAVE SLIPPED INTO THE ANEURYSM SAC. THE PHYSICIAN ELECTED TO IMPLANT TWO OVATION IX ILIAC LIMBS BY EXTENDING INTO THE EXTERNAL ILIAC ARTERY. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT DID WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 24712324 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2025 WITH A POSSIBLE KIDNEY INFECTION, AND IT WAS THEN REALIZED THAT THE RIGHT COMMON ILIAC LIMB EXTENSION HAD A DISEASED ANEURYSM SEGMENT WHICH CONTINUED AND DISEASE PROGRESSION. REINTERVENTION TOOK PLACE ON (B)(6) 2025 IN WHICH THE PHYSICIAN DECIDED TO COIL EMBOLIZE THE RIGHT INTERNAL ILIAC ARTERY (RIIA) AND EXTEND THE LIMB FURTHER INTO THE EXTERNAL ILIAC ARTERY BY IMPLANTING AN OVATION IX ILIAC LIMB. THE PATIENT ALSO HAD AN EXTREMELY PATENT INFERIOR MESENTERIC ARTERY (IMA) SO THE PHYSICIAN ALSO COIL EMBOLIZED THE IMA VIA SUPERIOR MESENTERIC ARTERY. IT IS BELIEVED THAT THE PATIENT HAD A PATENT TYPE II ENDOLEAK (NON-DEVICE RELATED) WHICH WAS CAUSING THE SAC EXPANSION FROM THE IMA. THE PATIENT STATUS WAS REPORTED TO BE DOING WELL AND RECOVERING FROM THE PROCEDURE. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED HOME FROM SUBACUTE REHAB ON POSTOPERATIVE DAY TWENTY IN FAIR CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak; Unspecified Infection

  MAUDE report 23556185 ↗
• InjuryMar 27, 2024Obstruction of Flow; Deformation Due to Compressive Stress; Device Stenosis; Obstruction of Flow; Deformation Due to Compressive Stress; Device Stenosis

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANTATION OF THE ALTO STENT GRAFT SYSTEM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE AORTIC ANATOMY SHOWED TWO 90-DEGREE INFRARENAL ANGLES. THE POLYMER WAS MIXED PER THE INSTRUCTIONS FOR USE (IFU), ATTACHED TO THE POLYMER PORT, AND ADVANCED WITH AN AUTOINJECTOR. INITIALLY, THE IPSILATERAL LIMB FILLED, BUT NOT THE RINGS OR CONTRALATERAL LIMB. THE PHYSICIAN THEN MOVED THE HANDLE OF THE ALTO DELIVERY SYSTEM AND PROCEEDED TO PUT A LITTLE BACK TENSION ON THE DELIVERY SYSTEM AND INFLATE THE INTEGRATED BALLOON. THE SEALING AND SUPPORT RING WERE PARTIALLY FILLED AFTER TROUBLESHOOTING. THE CONTRALATERAL LIMB NEVER FILLED. THE PHYSICIAN THEN CANNULATED THE CONTRALATERAL GATE USING THE CROSSOVER LUMEN, AND THE CONTRALATERAL LIMB DEPLOYED WITHOUT DIFFICULTY. THE ALTO DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED WITHOUT ANY COMPLICATIONS. THE IPSILATERAL LIMB ALSO DEPLOYED WITHOUT ANY DIFFICULTY. AN ANGIOGRAM SHOWED A TYPE IA ENDOLEAK, SO THE PHYSICIAN THEN DEPLOYED A (NON-ENDOLOGIX DEVICE) 40/10 PALMAZ AT THE RINGS. THIS SUCCESSFULLY RESOLVED THE TYPE IA ENDOLEAK. THE PATIENT'S STATUS WAS REPORTED AS HAV

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 18986377 ↗
• InjuryMar 21, 2024Material Invagination; Obstruction of Flow; Deformation Due to Compressive Stress; Material Invagination; Obstruction of Flow; 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 TWO (2) DAYS POST INITIAL PROCEDURE, THE PATIENT RETURNED WITH RIGHT LEG PAIN. THE CT (COMPUTED TOMOGRAPHY) SCAN NOTED THAT THE RIGHT ILIAC LIMB WAS KINKED AND HAD THROMBUS WITHIN GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH THROMBECTOMY AND IMPLANTED AN OVATION IX ILIAC LIMB. PATIENT IS REPORTEDLY STABLE, AND THROMBUS WAS SUCCESSFULLY RESOLVED.

  Patient problems: Clinical Endoleak; Obstruction/Occlusion; Pain; Thrombosis/Thrombus

  MAUDE report 18952431 ↗
• InjuryJul 12, 2023Migration; Migration

  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 WAS READMITTED ON 17 FEBRUARY 2023 FOR COILING OF THE LEFT INTERNAL ILIAC ARTERY WITH LEFT ILIAC STENT PLACEMENT DUE TO A TYPE IB ENDOLEAK, LEFT ILIAC PSEUDOANEURYSM, CRANIAL MIGRATION AND ANEURYSM ENLARGEMENT. THE PATIENT WAS DISCHARGED FOR A BRIEF PERIOD. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INITIAL REPORT. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED THAT A SUSPECT, CONTAINED RUPTURE IN THE PATIENT'S AORTA WAS INDICATED PER INTERNAL CLINICAL DOCUMENTATION DATED 16 FEBRUARY 2023. IN ADDITION, AORTIC STENOSIS WAS INDICATED PER INTERNAL CLINICAL DOCUMENTATION AND CT (COMPUTED TOMOGRAPHY) SCANS DATED 19 DECEMBER 2022 AND 16 FEBRUARY 2023.

  Patient problems: Aneurysm; Clinical Endoleak; Pseudoaneurysm; Ruptured Aneurysm; Stenosis

  MAUDE report 17311557 ↗

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