Valiant Navion™ VNMF3131C97TU (UDI 00763000260385)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260385), received between Oct 21, 2022 and Oct 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AORTIC ULCER.  IT WAS REPORTED THAT CORELAB HAVE REVIEWED A CT , AND HAVE IDENTIFIED A TYPE IA ENDOLEAK. NO FRACTURE, STENT RING ENLARGEMENT/MIGRATION OR AORTIC ENLARGEMENT WERE IDENTIFIED.   NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650624 ↗