Valiant Navion™ VNMF4040C183TU (UDI 00763000260514)Recalls & reported problems
Medtronic, Inc. · STENT GRAFT VNMF4040C183TU VAL NAV FF · Class 3 · Implant
All models of Valiant Navion (137)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260514), received between Aug 23, 2022 and Aug 23, 2022 — classified as 1 death.
The most frequently reported specific device problem is “Leak/Splash” (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
- 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
Device problems
- Leak/Splash1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 23, 2022Leak/Splash; Leak/Splash
VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION . IT WAS REPORTED AROUND 19 MONTHS LATER, THE PATIENT PRESENTED EMERGENTLY. SURGERY TO EXPLANT THE NAVION GRAFT DUE TO CONCERN FOR INF ECTION WASCOMPLETED. THE NAVION GRAFT WAS FOUND TO HAVE HOLES IN IT FOLLOWING THE EXPLANT. IT WAS REPORTED THE PATIENT EXPIRED SHORTLY AFTER THE EXPLANT PROCEDURE. NO CAUSE FOR THE HOLES IN THE GRAFT, INFECTION AND DEATH WERE PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 15275406 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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