Ovation iX Iliac Stent Graft TV-IL1410120-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850007370138), received between Oct 25, 2022 and Jan 31, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Lack of Effect” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2025Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2024, THE PATIENT UNDERWENT IMPLANTATION OF THE ALTO STENT GRAFT SYSTEM FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). ON (B)(6) 2025, A CLINICAL STUDY REPORTED THAT THE PATIENT WAS DIAGNOSED WITH STENT STENOSIS, ATTRIBUTED TO PROXIMAL COMPRESSION OF THE BILATERAL ILIAC LIMBS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Stenosis

  MAUDE report 21284380 ↗
• InjuryMay 17, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) AND DISSECTION. APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE AN AORTOGRAM REVEALED A POSSIBLE DISTAL TYPE 1B ENDOLEAK OF THE RIGHT ILIAC LIMB OR CONTINUED RETROGRADE FLOW INTO THE DISSECTION. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX EXTENDER TO RESOLVE THIS EVENT. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 19347216 ↗
• InjuryMar 21, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO AND HALF (2.5) YEARS POST INITIAL PROCEDURE DURING ROUTINE FOLLOW UP A TYPE 1B ENDOLEAK ON THE LEFT ILIAC WAS IDENTIFIED. ON (B)(6) 2024, THE PHYSICIAN ELECTED TO COIL THE LEFT HYPOGASTRIC ARTERY AND IMPLANT AN OVATION IX LIMB EXTENSION IN THE EXTERNAL ILIAC ARTERY ON THAT SIDE TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT DID WELL AND WAS DISCHARGED HOME.

  Patient problems: Clinical Endoleak

  MAUDE report 18952427 ↗
• InjuryOct 25, 2022Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) WEEKS POST INITIAL PROCEDURE, A FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED THAT THE PATIENT¿S RIGHT LIMB HAS THROMBOSED. IT WAS REPORTED THAT THERE IS A POSSIBILITY THAT THE LIMB THROMBOSIS COULD BE FROM THE PERCLOSE (NON-ENDOLOGIX) DEVICE; HOWEVER, THAT COULD NOT BE DETERMINED WITHOUT EVALUATING THE CT. IT WAS ALSO REPORTED THAT THERE WAS SEVERE COMMON FEMORAL ARTERY STENOSIS WHICH MAY BE THE CAUSE OF THE EVENT. THE PATIENT WAS SYMPTOMATIC AND WAS REFERRED TO ANOTHER FACILITY WHERE A FEM-FEM BYPASS PROCEDURE WAS PERFORMED TO RESOLVE THIS EVENT.

  Patient problems: Failure of Implant; Thrombosis/Thrombus

  MAUDE report 15670836 ↗

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