Valiant Navion™ VNMF4034C185TU (UDI 00763000260668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260668), received between Jan 27, 2022 and Jan 27, 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.

• MalfunctionJan 27, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN AORTIC DISSECTION WITH MALPERFUSION.  IT WAS REPORTED ON ONE MONTH FOLLOW-UP CT THAT THERE WAS A PRESENCE OF A TYPE IA ENDOLEAK. THE PATIENT HAD TINGLING IN HIS TOES AND LEFT SCAPULA PAIN SO THE PATIENT HAD MULTIPLE CT SCANS IN MAY AND JUNE. THE AORTA HAS GROWN OVER TIME AND THE LAST IMAGE SHOWS THE AORTA IS NOW 50MM IN SIZE.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS DUE TO THE PATIENTS OWN ANATOMY AS A RESULT OF A TEAR AT THE LEFT SUBCLAVIAN ARTERY.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Pain

  MAUDE report 13365968 ↗