THERMAGE FLX TT16.00F6-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816995021360), received between May 10, 2024 and Sep 5, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Excessive Heating” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A BURN TO THEIR SUPRAUMBILICAL AREA DURING A THERMAGE FLX BODY TREATMENT. THE PATIENT HAD RECEIVED THERMAGE FLX TREATMENT TO THEIR ABDOMEN AND LEGS. AFTER THE INJURY OCCURRED, THE PATIENT WAS TREATED WITH LA ROCHE-POSAY BRANDED CICAPLAST BALM. THE PATIENT¿S CURRENT STATUS IS THEY ARE HEALING HOWEVER HYPOPIGMENTED SPOTS ARE EXPECTED. THE PATIENT TAKES MAGNESIUM AND HYDROLYZED COLLAGEN, AS WELL AS APPLYING MOISTURIZING CREAM, ON A DAILY BASIS. THE PATIENT HAS NOT RECEIVED ANY OTHER TREATMENT TO THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT HAS NEVER RECEIVED TREATMENT TO THE SAME SYMPTOM AREA IN THEIR PAST HISTORY. A SOLTA MEDICAL REVIEWER EXAMINED TWO IMAGES OF THE PATIENT¿S ABDOMEN. ONE IMAGE SHOWED A BLISTER AROUND THE UMBILICUS, WHILE THE OTHER DEPICTED A SMALL BLISTER WITH SURROUNDING ERYTHEMA. NO DATES WERE PROVIDED FOR THE IMAGES. SOLTA MEDICAL BRANDED CRYOGEN AND 4 BOTTLES OF CRYOGEN WERE USED WITH THE HIGHEST LEVEL OF TREATMENT AT 1.5. THE INJURY REPORTEDLY OCCURRED DURING THE ¿FIRST PASS¿ IN THE ABDOMEN AREA. IT IS NOT KNOWN IF THE PROVIDER USED A STAMPING OR SLIDING METHOD. NO SYSTEM ERR

  Patient problems: Blister; Burn(s); Erythema; Hypopigmentation

  MAUDE report 22979940 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED TO A DISTRIBUTOR THAT A PATIENT SUSTAINED A 1.5 X 1.5 CM SECOND DEGREE BURN TO THE RIGHT MEDIAL UPPER ARM TWO DAYS POST BILATERAL ARMS THERMAGE FLX TREATMENT. AVAILABLE IMAGES OF THE PATIENT¿S INNER UPPER ARM WERE REVIEWED BY THE MEDICAL REVIEWER. SEVERAL UNDATED PHOTOGRAPHS DEPICT A WOUND APPROXIMATELY 1 X 1 INCH IN SIZE, LOCATED ON THE INNER ASPECT OF THE UPPER ARM. THE IMAGES CAPTURE THE WOUND AT VARIOUS STAGES OF THE HEALING PROCESS. EARLY IMAGES SHOW AN OPEN WOUND WITH RAW TISSUE EXPOSURE, WHILE SUBSEQUENT IMAGES DEMONSTRATE PROGRESSIVE IMPROVEMENT WITH FORMATION OF GRANULATION TISSUE AND PARTIAL RE-EPITHELIALIZATION. IN THE LATEST AVAILABLE IMAGES, THE WOUND APPEARS FULLY CLOSED, THOUGH RESIDUAL ERYTHEMA AND MILD LOCALIZED INFLAMMATION ARE STILL PRESENT, INDICATING ONGOING TISSUE REMODELING. THE PATIENT RECEIVED WOUND CARE WITH SILVADENE® (SILVER SULFADIAZINE), AND DRESSING CHANGES EVERY TWO DAYS. THE CURRENT STATUS WAS REPORTED AS STABLE; HOWEVER, THE FINAL OUTCOME REMAINS UNKNOWN. THE PATIENT IS NOT TAKING ANY REGULAR (PRESCRIPTION OR NON-PRESCRIPTION) MEDICATIONS, VITAMINS, OR HERBAL SUPPLEMENTS, NOR IS THE PATIENT USING ANY TOPICAL PRODUCT (BOTH M

  Patient problems: Burn(s); Erythema; Partial thickness (Second Degree) Burn; Skin Inflammation/ Irritation

  MAUDE report 22731651 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED TO A DISTRIBUTOR THAT A PATIENT EXPERIENCED SEVERE BURNS ON THE RIGHT INNER THIGH, ALONG WITH BURNS ON THE LEFT KNEECAP, ELBOW AND CHIN AREA TWO HOURS POST THERMAGE FLX PROCEDURE. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. THREE PHOTOS TAKEN 7 DAYS POST TREATMENT REVEALED CRUSTED WOUNDS LOCATED ON THE INNER THIGH OF ONE LEG AND THE LATERAL ASPECT OF THE KNEE ON THE OPPOSITE LEG. FOLLOW-UP IMAGING 1 MONTH AND 4 DAYS POST TREATMENT INCLUDED FOUR PHOTOGRAPHS. THESE DEMONSTRATED THAT THE WOUND ON THE LATERAL KNEE HAD HEALED, WITH RESIDUAL POST-INFLAMMATORY HYPERPIGMENTATION. IN CONTRAST, THE WOUNDS ON THE INNER THIGH OF THE CONTRALATERAL LEG HAD NOT FULLY HEALED. WHILE THE CRUSTS WERE NO LONGER PRESENT, THE UNDERLYING SKIN APPEARED ERYTHEMATOUS AND IN THE PROCESS OF RE-EPITHELIALIZATION, INDICATING INCOMPLETE HEALING. INFORMATION PROVIDED DESCRIBES APPROXIMATELY 4¿5 LESIONS, MEASURING 2 X 2 CM AND 1 X 1 CM IN SIZE, DESCRIBED AS SECOND AND THIRD-DEGREE BURNS WITH AREAS OF NECROSIS, LOCATED ON THE RIGHT INNER THIGH. THE PATIENT RECEIVED WOUND CARE, DRESSINGS EVERY 2-3 DAYS WITH 2 SESSIONS OF DEBRIDEMENT, AND A TOPICAL BURN CREAM (PRODUCT NOT SPECIF

  Patient problems: Erythema; Full thickness (Third Degree) Burn; Hyperpigmentation; Necrosis; Partial thickness (Second Degree) Burn

  MAUDE report 22731647 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED MULTIPLE 2ND DEGREE BURNS ON THEIR ABDOMEN FOLLOWING A THERMAGE FLX BODY TREATMENT. THE REPORT WAS RECEIVED APPROXIMATELY 65 DAYS POST-PROCEDURE, IT IS UNKNOWN WHEN SYMPTOMS WERE FIRST OBSERVED. THE PATIENT WAS GIVEN AN UNKNOWN OINTMENT FOR THEIR INJURIES AND HEAT OR ICE WAS APPLIED POST PROCEDURE. THE PATIENT DID NOT TREAT THEIR BURN WITH ANY OVER THE COUNTER SOLUTIONS AT HOME. THEIR CURRENT STATUS IS THEY ARE UNDERGOING LASER TREATMENT AND GRADUALLY RECOVERING. PERMANENT DAMAGE OR SCARRING IS EXPECTED. NO OTHER TREATMENTS WERE PERFORMED IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT DOES NOT HAVE A HISTORY OF RECEIVING AESTHETIC TREATMENTS IN THE SYMPTOM AREA. INFORMATION FOR THE CRYOGEN AND COUPLING FLUID USED IN THE TREATMENT WERE NOT PROVIDED. IT IS UNKNOWN IF A STAMPING OR SLIDING METHOD WAS USED. THE PATIENT WAS NOT ADMINISTERED ANY PAIN MEDICATION OR ANESTHESIA PRIOR TO THE TREATMENT. THEY WERE ALERT AND ABLE TO PROVIDE FEEDBACK DURING THE PROCEDURE. THE HIGHEST LEVEL OF TREATMENT WAS 5.5. NO SYSTEM ERRORS OCCURRED DURING THE TREATMENT. IT IS UNKNOWN IF THIS WAS THE FIRST TIME THE BODY

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21663802 ↗
• InjuryOct 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS AROUND THE BELLY BUTTON AFTER A THERMAGE FLX TREATMENT TO THE ABDOMEN, AND THAT THE BURNS SCARRED. THE FACILITY REPORTED THAT THE ENERGY LEVELS WERE MAINTAINED BETWEEN 0.5 ¿ 1.0 THROUGHOUT THE PROCEDURE. NO OTHER TREATMENTS WERE BEING PERFORMED AT THE SAME TIME IN THE SYMPTOM AREA, AND TO THE BEST OF THE PROVIDER¿S KNOWLEDGE NONE HAD BEEN PERFORMED WITHIN THE PRIOR NINETY DAYS. SOLTA CRYOGEN AND SIX TUBES OF SOLTA COUPLING FLUID WERE USED DURING THE TREATMENT. THE TREATMENT TIP WAS INSPECTED PRIOR TO THIS INITIAL USE, WITH NOTHING ATYPICAL NOTED. THE TREATMENT TIP WAS INSPECTED THROUGHOUT THE TREATMENT AND NO ANOMALIES WERE NOTED. THE PATIENT VISITED A DOCTOR APPROXIMATELY 13 DAYS AFTER THE TREATMENT AND WAS DIAGNOSED WITH A HYPERTROPHIC SCAR. SPOTTED SCARS WERE OBSERVED ON THE ABDOMINAL WALL. THE PATIENT SHOWED A PICTURE FROM THE DATE OF THE INCIDENT AND THE DOCTOR STATED IT'S LIKELY FROM A BURN. THE PATIENT STATED THE WOUND WAS PAINFUL BUT NOT ITCHY AND DENIED ANY OTHER CONCERN DURING THE TREATMENT. THREE PROVIDED UNDATED PICTURES WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER. IN THE FIRST PHOTO, NO INJURY IS VISIBLE. IN THE

  Patient problems: Blister; Burn(s); Erythema; Scar Tissue

  MAUDE report 20540657 ↗
• InjuryMay 10, 2024Excessive Heating; Excessive Heating

  THE PATIENT WAS INSTRUCTED TO USE DRESSING AND HYPERBARIC OXYGEN THERAPY. HEAT OR ICE AND OVER-THE-COUNTER TREATMENTS WERE APPLIED AT HOME BY THE PATIENT.

  Patient problems: Blister; Erythema; Partial thickness (Second Degree) Burn; Skin Inflammation/ Irritation; Superficial (First Degree) Burn; Swelling/ Edema

  MAUDE report 19290569 ↗