Trimedyne® VaporMAX® - Ho:YAG Side Firing Fiber-Optic Instrument 20444Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M473204440), received between Mar 2, 2019 and Mar 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Discolored” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2019Thermal Decomposition of Device; Material Discolored; Melted; Overheating of Device; Material Separation; Use of Device Problem; Thermal Decomposition of Device; Material Discolored; Melted; Overheating of Device; Material Separation; Use of Device Problem

  FIBER BROKE AT THE CONNECTOR WITHIN HALF A MINUTE AFTER BEING OPENED. THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE, INC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384306 ↗