THERMAGE FLX TH-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816995021278), received between Apr 18, 2024 and Nov 26, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Excessive Heating” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT WAS BURNED ON THE EYELIDS DURING A THERMAGE FLX TREATMENT. FURTHER EVENT DETAILS WERE REQUESTED; HOWEVER, THE CUSTOMER DECLINED TO SUPPLY ANY DETAILS.

  Patient problems: Burn(s)

  MAUDE report 20787298 ↗
• InjuryAug 18, 2024Insufficient Cooling; Excessive Heating; Insufficient Cooling; Excessive Heating

  A USER FACILITY REPORTED THAT DURING A THERMAGE FLX TREATMENT SESSION TO THE FACE, THE MACHINE STOPPED RELEASING CRYOGEN. THE ENERGY LEVEL WAS REDUCED AND THE PATIENT COMPLAINED THAT THE SENSATION WAS VERY HOT. THE TREATMENT WAS THEN TERMINATED IMMEDIATELY. ONE DAY POST TREATMENT, THE PATIENT CONTACTED THE USER FACILITY TO REPORT THAT SHE HAD SUFFERED BURNS TO THE FOREHEAD FROM THE THERMAGE TREATMENT AND SHOWED SIGNS OF INFECTION AND THAT THERE WERE SOME SCARS ON THE FOREHEAD AND HER CHEEKS ARE SAGGIER. THE NATURE OF THE INJURY IS REPORTED TO BE SCARS WITH SECONDARY INTERVENTION INCLUDING A SCAR CREAM (SAVLON) TO PREVENT SCARS AND PARACETAMOL TO DEAL WITH THE HEADACHE CAUSED BY EMOTION OF THE SITUATION. FIVE DAYS POST TREATMENT, IT WAS REPORTED THAT THE PATIENT WAS "OK AND THE MARKS ARE BARELY SEEN.¿ THE FACILITY HAS RECEIVED NO FURTHER UPDATES FROM THE PATIENT. AVAILABLE PICTURES (AT THE TIME OF THE REPORT) WERE REVIEWED BY THE MEDICAL REVIEWER AND ERYTHEMA AND SMALL BURNED AREAS WERE VISIBLE ON PATIENT'S FOREHEAD. ADDITIONAL PICTURES WERE RECEIVED A FEW DAYS AFTERWARDS. TWO PHOTOS TAKEN BEFORE THE TREATMENT DO NOT SHOW RED SPOTS ARE BURN MARKS WHILE PHOTOS AFTERWARDS SHOW RED SPO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s); Erythema; Eye Pain; Headache; Scar Tissue

  MAUDE report 19999061 ↗
• InjuryApr 18, 2024Leak/Splash; Excessive Heating; Leak/Splash; Excessive Heating

  A USER FACILITY REPORTED A CRYOGEN LEAKAGE BURN TO THE RIGHT SIDE OF THE PATIENT'S FACE THAT OCCURRED DURING A THERMAGE FLX TREATMENT. THE NATURE OF THE INJURY WAS REPORTED AS REDNESS, A RASH ALL AROUND THE FACE, BUBBLING, AND SENSATIONS OF HEAT AND STINGING. SECONDARY INTERVENTION INCLUDED BCN ASIAN CENTELLA AND B5, AND A EGF MASK TO APPLY POST TREATMENT. THE PATIENT'S CURRENT STATUS IS UNCERTAIN, AND IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. A CONSULTATION FOLLOW UP WAS MENTIONED. AN AVAILABLE PICTURE WAS REVIEWED BY THE MEDICAL REVIEWER. PINPOINT BROWN LESIONS ARE SCATTERED ON ONE SIDE OF THE PATIENT''S FACE. IT IS UNCLEAR IF THE LESIONS ARE CRUSTS OR POST INFLAMMATORY HYPERPIGMENTATION. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE PATIENT HAS NOT HAD PRIOR AESTHETIC TREATMENTS ON THE AFFECTED AREA. THE INCIDENT OCCURRED AT 193 REPS. THE HIGHEST ENERGY LEVEL USED WAS 2.5 MJ. ADDITIONALLY, AN ERROR MESSAGE OF "TIP TOO WARM" OCCURRED DURING THE TREATMENT.

  Patient problems: Cryogenic Burn; Erythema; Rash; Skin Burning Sensation

  MAUDE report 19140068 ↗