THERMAGE FLX TT0.25F6-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816995021346), received between Jul 2, 2024 and Nov 11, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Radiation Output 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Radiation Output Problem; Radiation Output Problem

  PER THE MOST RECENT FOLLOW-UP, THE TREATING FACILITY INDICATED THAT THERE IS A HIGH LIKELIHOOD OF PERMANENT SCARRING.

  Patient problems: Blister; Burn(s)

  MAUDE report 23525966 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A SUBCUTANEOUS CYSTIC NODULE UNDER THEIR RIGHT EYE FOLLOWING A THERMAGE FLX TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND AN UNKNOWN AMOUNT OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 2.5. EYE SHIELDS WERE INSERTED USING NEODEX EYE SHIELD LUBRICATION. THE PATIENT RECEIVED TREATMENT TO THEIR EYELIDS AND FACE WITH NO EQUIPMENT PROBLEMS AND NO PROCEDURE ISSUES. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED ON A PATIENT, AND IT WAS INSPECTED PRIOR TO THE PROCEDURE WITH NO DISCREPANCIES OBSERVED. THE TIP WAS NOT CHECKED AT ANY TIME DURING THE TREATMENT. THE PATIENT HAD RECEIVED LDM (LOCAL DYNAMIC MICRO-MASSAGE) ULTRASOUND TREATMENT IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE BUT DID NOT UNDERGO ANY OTHER TREATMENT WITHIN 30 DAYS PRIOR. APPROXIMATELY 21 DAYS POST-PROCEDURE THE PATIENT VISITED THE HOSPITAL WITH A COMPLAINT OF A SUBCUTANEOUS CYSTIC NODULE IN THE RIGHT ORBITAL REGION. A CYSTIC LESION MEASURING 6X3X5MM WAS CONFIRMED AND IT WAS PRESUMED THAT IT MAY BE AN EPIDERMAL CYST INDUCED BY EXTERNAL STIMULI. THE USER FACILITY DETERMINED SINCE NO PROBLEMS OCCURRED DURING THE THERMAGE FLX PROCEDURE, AND IT WA

  Patient problems: Cyst(s); Subcutaneous Nodule

  MAUDE report 20763698 ↗
• InjuryJul 2, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BURNS ON THE LOWER EYELID AFTER A THERMAGE FLX EYE TREATMENT. AN EYE SHIELD WAS USED TREATMENT DURING THE TREATMENT. THE DOCTOR REPORTED HAVING TROUBLE WITH THE TREATMENT AND COULD NOT PROGRESS AFTER 23 REPS DUE TO RECEIPT OF A RADIOFREQUENCY POWER ERROR/TUNING FAILURE. THE HIGHEST ENERGY LEVEL USED WAS 2.0. NO ADDITIONAL TREATMENTS WERE BEING PERFORMED AT THE SAME TIME AS THE THERMAGE FLX TREATMENT. SOLTA MEDICAL CRYOGEN AND COUPLING FLUID (1ML) WERE USED FOR THE TREATMENT. THIS WAS THE INITIAL USE OF THE TREATMENT TIP, WHICH WAS INSPECTED PRIOR TO TREATMENT BUT NOT THROUGHOUT THE TREATMENT. NO SECONDARY INTERVENTION WAS NECESSARY AS A RESULT OF THE BURN. TWO AVAILABLE PICTURES WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER. THE SEQUENCE OF PICTURES AND TIMING ARE UNCLEAR; THEREFORE, THE HEALING PROCESS CANNOT BE DETERMINED. ONE PICTURE SHOWS MINOR CRUSTS UNDER EYELID WITH ERYTHEMA ON THE CHEEK, AND THE SECOND PICTURE SHOWS A HYPERPIGMENTED LINE UNDER THE EYELID AND MINOR ERYTHEMA ON THE CHEEK. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE PATIENT¿S CURRENT STATUS IS UNKNOWN AND IT IS UNKNOWN IF THERE WILL BE PERMANENT D

  Patient problems: Burn(s); Erythema; Hyperpigmentation

  MAUDE report 19660793 ↗