Thermage TH-4RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850608002889), received between Jun 28, 2018 and Oct 23, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device 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. How this data works · Data updated Oct 13, 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.

• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT WHO RECEIVED A THERMAGE CPT TREATMENT APPROXIMATELY 15 MONTHS AGO HAS DEVELOPED A SMALL LUMP ON THE MID RIGHT QUAD WHERE THE TREATMENT WAS PERFORMED. THE EVENT WAS BROUGHT TO THE ATTENTION OF THE TREATING FACILITY APPROXIMATELY 10 MONTHS AFTER THE PROCEDURE. IT IS UNSURE IF THE LUMP IS RELATED TO THE TREATMENT. THE PATIENT¿S CURRENT STATUS WAS REPORTED AS HAVING A LUMP ON THE LEG WITH THE POSSIBILITY OF PERMANENT SCARRING OR DAMAGE. THE PATIENT IS NOT IN ANY PAIN AND LONG-TERM ISSUES ARE NOT ANTICIPATED. AN AVAILABLE PICTURE WAS REVIEWED BY THE MEDICAL REVIEWER; THE LUMP IS VISIBLE IN THE PICTURE. THE PERSON WHO PERFORMED THE TREATMENT NO LONGER WORKS AT THE REPORTING FACILITY, THEREFORE INFORMATION REGARDING THE TREATMENT IS LIMITED. IT WAS REPORTED THAT NO OTHER TREATMENTS WERE BEING PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED, AND THE PATIENT HAD NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE PATIENT WAS NOT UNDER ANESTHESIA, NOR DID THEY RECEIVE ANY PAIN MEDICATION. THE HIGHEST ENERGY LEVEL USED IS NOT KNOWN. BASED OFF THE PATIENT CHART, NO SYSTEM ERRORS OR ANYTHING OUT OF THE ORDINARY

  Patient problems: Nodule

  MAUDE report 20514832 ↗
• InjuryJun 28, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Burn(s)

  MAUDE report 7648166 ↗