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Valiant Navion™ VNMF4337C185TU (UDI 00763000260675)Recalls & reported problems

Medtronic, Inc. · STENT GRAFT VNMF4337C185TU VAL NAV FF TP · 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 00763000260675), received between Jan 25, 2021 and Jan 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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

Device problems

  • Activation, Positioning or Separation Problem1
  • Difficult or Delayed Positioning1

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.

  • MalfunctionJan 25, 2021Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem

    A VALIANT NAVION STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 70MM OF THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHEN THE SURGEON WAS PASSING THE DELIVERY SYSTEM UP INTO THE PROXIMAL THORACIC AORTA UP TO THE CAROTID IT WAS NOTED THE ANATOMY WAS VERY TORTUOUS WITH SEVERAL U-TURNS. IT WAS VERY DIFFICULT FOR THE SURGEON TO GET THE DEVICE UP INTO THE THORACIC AORTA. A LOT OF FRICTION HAD BUILT UP IN THE DELIVERY SYSTEM. THE SURGEON WENT TO DEPLOY THE GRAFT. THE BLUE HAND PIECE JUST SPUN AND THE SHEATH COVERING THE GRAFT WOULD NOT COME BACK. THE SURGEON REMOVED THIS STENT GRAFT OUT OF THE PATIENT AND INSTEAD WAS ABLE TO IMPLANT A SHORTER DEVICE SUCCESSFULLY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11222208 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page