Valiant Navion™ VNMF2525C185TU (UDI 00763000100568)Recalls & reported problems
Medtronic, Inc. · STENT GRAFT VNMF2525C185TU VAL NAV FF · Class 3 · Implant
All models of Valiant Navion (137)
Data updated Oct 16, 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 00763000100568), received between Mar 29, 2021 and Mar 29, 2021 — classified as 1 death.
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 16, 2026.
Recalls naming this device
- Feb 12, 2021Open, 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A COARCTATION OF THORACIC AORTA. APPROX 9 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH AN OCCLUDED AORTA. INTERVENTION WAS PERFORMED ON THE FOLLOWING TWO CONSECUTIVE DAYS WITH AN OPEN REPAIR. IT WAS REPORTED THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO AN OCCLUDED AORTA. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS EXPIRED.
Patient problems: Obstruction/Occlusion
MAUDE report 11580901 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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