Ovation iX Iliac Stent Graft TV-IL1428140-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850007370091), received between Dec 14, 2022 and May 13, 2024 — classified as 3 injuries.

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

• InjuryMay 13, 2024Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2024 IDENTIFIED OCCLUSION OF THE LEFT OVATION IX ILIAC LIMB. THE PHYSICIAN ELECTED TO RESOLVE THE OCCLUSION BY RELINING WITH A GORE (NON-ENDOLOGIX) VIABAHN STENT DURING REINTERVENTION CONDUCTED ON (B)(6) 2023. THE PATIENT WAS REPORTED AS DOING WELL POST-SECONDARY PROCEDURE.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 19306250 ↗
• InjuryApr 3, 2024Collapse; Obstruction of Flow; Collapse; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. APPROXIMATELY TWO (2) MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A THROMBOSED LEFT ILIAC LIMB. THE PHYSICIAN ELECTED TO PERFORM A PROCEDURE TO ADDRESS THE THROMBOSIS, INCLUDING MECHANICAL CLOT REMOVAL AND RELINING OF THE LIMB WITH A GORE (NON-ENDOLOGIX) VBX STENT GRAFT AND AN OVATION IX ILIAC LIMB. ADDITIONALLY, THE OTHER LIMB RECEIVED A GORE (NON-ENDOLOGIX) VBX STENT GRAFT (KISSING STENTS) TO MAINTAIN PATENCY. THE PATIENT'S STATUS WAS REPORTED AS STABLE FOLLOWING THE SECONDARY PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19030446 ↗
• InjuryDec 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ENDOVASCULAR IMPLANT THE ALTO STENT GRAFT SYSTEM. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, A TYPE IIIA ENDOLEAK WAS IDENTIFIED AT THE ROUTINE FOLLOW-UP. REINTERVENTION INFORMATION HAS NOT BEEN PROVIDED. THE PATIENT STATUS HAS NOT BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15980402 ↗

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