NeuroTherm™ RF-DGP-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067023612), received between Sep 3, 2019 and Sep 3, 2019 — classified as 1 malfunction.

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

• MalfunctionSep 3, 2019Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

  Patient problems: Irritation

  MAUDE report 8958527 ↗