Valiant Navion™ VNMF2828C174TU (UDI 00763000260378)Recalls & reported problems
Medtronic, Inc. · STENT GRAFT VNMF2828C174TU 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
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260378), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 malfunction.
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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2022Leak/Splash; Leak/Splash
A VALIANT NAVION WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ANEURYSM. IT WAS REPORTED THAT CORELAB IDENTIFIED A TYPE IIIB ENDOLEAK ON CT SCAN FROM (B)(6) 2021. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WERE OBSERVED. THE IMAGING WAS NOTED AS N/A FOR AORTIC ENLARGEMENT. NO CAUSE OF THE ENDOLEAK WAS PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15922345 ↗
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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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