Viant Medical, LLC T5326Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840096401400), received between Sep 13, 2024 and Sep 14, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2024Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement; Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A 67 YEAR OLD PATIENT THAT WHILE REAMING THE SHAFT STARTED TO WOBBLE BECAUSE THE CONNECTION AT THE GUN BENT. THE SURGERY WAS COMPLETED AS INTENDED WITH NO DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218754 ↗
• MalfunctionSep 13, 2024Unstable; Unintended Movement; Unstable; Unintended Movement

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A 65 YEAR OLD MALE PATIENT THAT THE REAMER SEEMED WOBBLY. THE MALFUNCTION OCCURRED AWAY FROM THE PATIENT. ANOTHER TRAY WAS OPENED AND A DIFFERENT REAMER HANDLE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE WITH A ONE MINUTE DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218258 ↗