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Valiant Navion™ VNMF4343C183TU (UDI 00763000260552)Recalls & reported problems

Medtronic, Inc. · STENT GRAFT VNMF4343C183TU 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
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260552), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Aneurysm1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 68MM TAA. IT WAS REPORTED ON AN UNKNOWN DATE, A CTA PERFORMED SHOWED THE ENDOGRAFT EXTENDING DOWN TO LOWER THORACIC AORTA, ENDOGRAFT WAS PATENT  AND THE  FUSIFORM ANEURYSM OF THE AORTA IS LARGER THAN PREVIOUS. 7.7CM TRANSVERSE INTERVAL INCREASE IN THE SIZE OF FUSIFORM THORACOABDOMINAL ANEURYSM. INTERVENTION WAS PERFORMED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE. 3 NON MDT STENT GRAFTS WERE IMPLANTED TO RELINE THE NAVION STENT GRAFTS TO EXTEND  THE GRAFT JUST ABOVE THE CELIAC ARTERY AND RIGHT AXILLARY. THE PROCEDURE ALSO INCLUDED A  FEMORAL BYPASS  TO RIGHT  AXILLARY FEMORAL ARTERY BYPASS W/ PTFE THORACIC ENDOGRAFT PLACEMENT W/O LEFT SUBCLAVIAN ARTERY COVERAGE. RIGHT AXILLARY BYPASS W/ PTFE EXTENSION OF THORACIC ENDOGRAFT DISTALLY. A CT PERFORMED POST THE INTERVENTION WAS REPORTED AS GOOD.  PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

    Patient problems: Aneurysm

    MAUDE report 17340427 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

Sources and updates

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