Viant Medical, LLC T17621Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840096400595), received between Jul 15, 2022 and Sep 12, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

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 12, 2023Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT AFTER REAMING WITH THE 52MM (VIANT) REAMER, THE 52MM (IMPLANT) CUP WOULD NOT STICK WHEN IMPLANTED. ANOTHER 52MM (IMPLANT) CUP WAS TRIED AND IT ALSO DID NOT STICK. THE PROCEDURE WAS CONTINUED BY REAMING UP TO 54MM AND IMPLANTING A 54MM (IMPLANT) CUP INSTEAD WITH A 3-5 MINUTE DELAY. IT WAS SPECULATED THAT THERE WAS A MISMATCH IN SIZE BETWEEN THE 52MM (IMPLANT) CUP AND 52MM (VIANT) REAMER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730752 ↗
• MalfunctionJul 15, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE 52MM GRATER IS DULL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028197 ↗