Valiant Navion™ VNMC3125C207TU (UDI 00763000101220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000101220), received between Oct 17, 2022 and Jul 31, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 12, 2021Class IOpen, Classified

   Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

   Z-1201-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A DISSECTION ON (B)(6) 2020. IT WAS REPORTED VIA CORE LAB REVIEW OF FILMS APPROXIMATELY 4 YEARS AND 3 MONTHS POST IMPLANT THAT STENT RING ENLARGEMENT WAS IDENTIFIED IN (B)(6). NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677311 ↗
• MalfunctionOct 17, 2022Leak/Splash; Leak/Splash

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

  Patient problems: Dyspnea; Hypoxia; Pain

  MAUDE report 15614620 ↗