Trimedyne® VaporMax® - Ho:YAG Side Firing Fiber-Optic Instrument 20444-SMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M47320444SMA0), received between Mar 2, 2019 and Mar 2, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (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.

• 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 NEEDLE IS POOR BLASTING FORCE WITH BLACKENING AND OUTPUTTING ENERGY AFTER USING FOR MORE THAN TEN MINUTES. THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE, INC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384314 ↗
• 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 NEEDLE IS POOR BLASTING FORCE WITH BLACKENING AND OUTPUTTING ENERGY AFTER USING FOR MORE THAN TEN MINUTES. THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE, INC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384302 ↗