THERMAGE FLX TT4.00F6-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00816995021421), received between Mar 20, 2024 and Mar 25, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED A LOCALIZED SKIN DEPRESSION ON THE PATIENT'S CHEEK APPROXIMATELY 10 WEEKS POST THERMAGE FLX TREATMENT. THE PROCEDURE REPORTEDLY INCLUDED ENERGY-BASED SKIN TIGHTENING CONSISTENT WITH THERMAGE TREATMENT TO THE FACIAL REGION. APPROXIMATELY 10 WEEKS POST-PROCEDURE, THE PATIENT CONTACTED THE CLINIC TO REPORT A VISIBLE CONTOUR CHANGE IN THE TREATED CHEEK AREA. THE PATIENT DESCRIBED A LOCALIZED DEPRESSION AT THE PRIOR TREATMENT SITE. AT FOLLOW-UP EVALUATION, A LOCALIZED SKIN DEPRESSION WAS OBSERVED IN THE CHEEK REGION CORRESPONDING TO THE AREA OF TREATMENT. NO SECONDARY INTERVENTIONS HAD BEEN INITIATED AT THE TIME OF REPORTING. THE CURRENT STATUS REMAINS ONGOING AT LAST FOLLOW-UP, WITH PERSISTENCE OF THE LOCALIZED CONTOUR DEFECT. THERE IS A POSSIBILITY OF PERMANENT COSMETIC CHANGE OR SCARRING. TWO SUBMITTED IMAGES WERE REVIEWED BY THE MEDICAL REVIEWER OVERALL, THE PHOTOGRAPHIC FINDINGS ARE CONSISTENT WITH LOCALIZED SOFT TISSUE ATROPHY OR CONTOUR DEFORMITY - SOFT TISSUE VOLUME LOSS OR FOCAL SUBCUTANEOUS ATROPHY. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED, NOR HAS THE PATIENT UNDERGONE ANY OTHER TREA

  Patient problems: Atrophy

  MAUDE report 24695113 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT DEVELOPED BLISTERS, REDNESS, AND PAIN ON THE FACE THE DAY AFTER RECEIVING A THERMAGE FLX TREATMENT. IT WAS REPORTED THAT NEOSPORIN, VASELINE, EXTENSIVE MOISTURIZER, A SMALL DOSE OF HYDROCORTISONE 1% CREAM, AND AN UNSPECIFIED NUMBING MEDICATION IS BEING USED FOR THE PATIENT AS A SECONDARY INTERVENTION. AS OF ONE MONTH POST PROCEDURE, THE PATIENT IS STILL RECOVERING, AND THE POSSIBILITY OF ANY PERMANENT DAMAGE OR SCARRING REMAINS UNKNOWN. IT WAS CONFIRMED THAT THE PATIENT USES AN UNSPECIFIED TOPICAL CREAM ON A REGULAR BASIS, BUT NOT TAKING ANY OTHER PRESCRIPTION OR NON-PRESCRIPTION MEDICATIONS OR SUPPLEMENTS ON A REGULAR BASIS. AVAILABLE PHOTOS FROM TWO DAYS AFTER THE PROCEDURE WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER, WHICH IDENTIFIED THAT BOTH CHEEKS APPEAR TO HAVE BURN INJURIES WITH VISIBLE ERYTHEMA AND INFLAMMATION. THE AFFECTED AREA IS MORE PROMINENT ON ONE SIDE, WHILE THE INVOLVEMENT OF THE OTHER SIDE IS LESS APPARENT DUE TO LIMITED IMAGE CAPTURE. THE SOLTA MEDICAL REVIEWER ALSO ASSESSED PHOTOS THAT WERE REPORTEDLY TAKEN SIXTEEN DAYS AFTER THE PROCEDURE, AND IT WAS IDENTIFIED THAT INFLAMMATION HAS SUBSIDED. MILD ERYTHEMA REMAINS VISIBL

  Patient problems: Blister; Burn(s); Erythema; Pain; Skin Inflammation/ Irritation

  MAUDE report 22796159 ↗
• InjuryMay 28, 2025Excessive Heating; Excessive Heating

  A USER FACILITY REPORTED A BURN TO THE FACE FOLLOWING A THERMAGE FLX TREATMENT. PHOTOGRAPHIC DOCUMENTATION WAS REVIEWED BY THE MEDICAL REVIEW. TWO PRE-PROCEDURE IMAGES, DATED THE DAY OF TREATMENT, AND TWO POST-PROCEDURE IMAGES, DATED TWO DAYS POST TREATMENT, WERE AVAILABLE FOR EVALUATION. THE POST-TREATMENT IMAGES SHOW VISIBLE BURNED AREAS LOCALIZED TO ONE SIDE OF THE PATIENT'S CHEEK. SMALL WOUNDS AND CRUSTED LESIONS ARE OBSERVED ALONG THE AFFECTED AREA. THE TREATMENT WAS REPORTED AS SECOND PRESCRIPTION OVERVIEW AND WAS NOTED THAT FOLLOWING CLINICAL RE-EVALUATION OF THE PATIENT¿S POST-PROCEDURAL SKIN CONDITION, A SECOND PRESCRIPTION REGIMEN WAS INITIATED TO SUPPORT WOUND MATURATION AND REDUCE THE RISK OF POST-PROCEDURAL SEQUELAE. THE FOLLOWING TOPICAL AGENTS AND DRESSING MATERIALS HAVE BEEN PRESCRIBED: ESROBAN ¿ TOPICAL ANTIMICROBIAL DRESSING FOR PROTECTION AND WOUND MANAGEMENT EGF DAEWOONG ¿ EPIDERMAL GROWTH FACTOR (EGF)-CONTAINING AGENT TO PROMOTE EPITHELIAL REGENERATION. MEDIFOAM ¿ POLYURETHANE FOAM DRESSING TO MAINTAIN A MOIST WOUND ENVIRONMENT CONDUCIVE TO HEALING. NOSCARNA ¿ TOPICAL AGENT INTENDED FOR SCAR PREVENTION AND MODULATION OF FIBROPROLIFERATIVE ACTIVITY. IN ADDITION,

  Patient problems: Burn(s); Hyperpigmentation

  MAUDE report 22099695 ↗
• InjuryMay 22, 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 SECOND-DEGREE BURN TO THE FOREHEAD ONE DAY AFTER A THERMAGE FLX TREATMENT. NO SYMPTOMS WERE NOTICED ON THE DAY OF THE PROCEDURE. THE PATIENT NOTICED THE SYMPTOMS AT HOME THE FOLLOWING DAY. NO SECONDARY INTERVENTION WAS ADMINISTERED TO TREAT THE BURN. AN AVAILABLE PICTURE WAS REVIEWED BY THE SOLTA MEDICAL REVIEWER, WHICH IDENTIFIED A SMALL, LOCALIZED AREA OF DISCOLORATION THAT IS CONSISTENT WITH A BURN ON THE UPPER PORTION OF THE PATIENT¿S FOREHEAD. APPROXIMATELY SEVEN WEEKS POST-TREATMENT, IT WAS REPORTED THAT THE PATIENT HAS NOT FULLY RECOVERED; HOWEVER, THE PATIENT HAS NOT YET RETURNED TO THE CLINIC FOR FOLLOW UP TREATMENT. THE POSSIBILITY OF PERMANENT DAMAGE OR SCARRING REMAINS UNKNOWN. NOTHING ATYPICAL WAS OBSERVED DURING THE THERMAGE FLX TREATMENT. NO SYSTEM ERRORS OCCURRED DURING THE TREATMENT. THE UNUSED TREATMENT TIP WAS INSPECTED PRIOR TO STARTING THE PROCEDURE AND REINSPECTED EVERY 100 PULSES WITH NO ABNORMALITIES NOTED. THE PROCEDURE WAS REPORTEDLY COMPLETED AT 600 SHOTS WITH THE HIGHEST ENERGY USED BEING 2.5MJ. THE USER FACILITY CONFIRMED USING SOLTA CRYOGEN AND APPROXIMATELY 60ML OF SOLTA COUPLING FLUID TO COMPLETE

  Patient problems: Partial thickness (Second Degree) Burn; Skin Discoloration

  MAUDE report 22071160 ↗
• InjuryOct 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A USER FACILITY REPORTED A BLISTER TO THE PATIENT'S NECK ONE DAY POST THERMAGE FLX TREATMENT. AN AVAILABLE PICTURE WAS REVIEWED BY THE MEDICAL REVIEWER AND THREE TO FOUR MINOR BLISTERS WERE VISIBLE ON PATIENT'S NECK. THE PATIENT WAS TREATED WITH TOPICAL CORTICOSTEROID AND THE PATIENT'S CURRENT STATUS IS LISTED AS A RESIDUAL ERYTHEMATOUS LESION. IT IS UNKNOWN IF THERE BE ANY PERMANENT DAMAGE OR SCARRING. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS, NOR HAS THE PATIENT EVER HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA. THE PATIENT WAS NOT ADMINISTERED ANY PAIN MEDICATION OR PLACED UNDER ANESTHESIA. THE INCIDENT OCCURRED BETWEEN 2-3 REPS. WHEN ASKING THE CUSTOMER IF A SYSTEM ERROR OR SOMETHING OUT OF THE ORDINARY WAS NOTICED DURING TREATMENT, THEY REPLIED YES BUT DID NOT PROVIDE DETAILS. A STAMPING METHOD WAS USED. SOLTA CRYOGEN AND 3/4 A BOTTLE OF SOLTA UNSCENTED COUPLING FLUID WERE USED. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND NOTHING REMARKABLE WAS NOTED. THE TREATMENT TIP SURFACE WAS NOT INSPECTED DURI

  Patient problems: Blister; Erythema; Hyperpigmentation; Localized Skin Lesion

  MAUDE report 20358464 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BLISTERS TO THE BACK OF THE LEG AFTER A THERMAGE FLX TREATMENT TO THE UPPER KNEE. BLISTERS WERE OBSERVED ON THE BACK OF THE THIGH. IT WAS REPORTEDLY A DELAYED EVENT, AS NO ERYTHEMA, OEDEMA OR HEAT WAS PRESENT IMMEDIATELY POST TREATMENT. NOTHING ATYPICAL WAS OBSERVED DURING THE TREATMENT. A STAMPING METHOD WAS USED, WITH COPIOUS SOLTA COUPLING FLUID AND SOLTA CRYOGEN. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE AND EVERY FIFTY PULSES, WITH NO PROBLEMS NOTED. THE TREATMENT LEVEL ENERGY WAS LOW, AT 1-3. THE RETURN PAD WAS PLACED ON THE PATIENT¿S LOWER BACK. THE TREATMENT WAS FINISHED EARLY DUE TO THE PATIENT NOT EXPERIENCING ANY CLINICAL ENDPOINT AND BECAUSE THE MODEL DID NOT WANT TO INCREASE THE TREATMENT LEVEL. A SOLTA CLINICAL TRAINER WITNESSED THIS TREATMENT ON THE FRONT OF THE LEG, SUPERIOR TO THE KNEE, AND SLIGHTLY LATERAL. THE TRAINER NOTED THAT THE MODEL WAS FLAT ON HER BACK WITH THE LEG FLAT ON THE BED, AND THERE IS NO WAY THAT DEVICE COULD HAVE TOUCHED THIS AREA OF THE LEG. THE AFFECTED AREA OF THE LEG WAS ALSO NOT GRID, AND THERE WAS NO ACCESS TO THE BACK OF THE THIGH. THE BLISTERING WAS REPORTED TO THE CLINICAL TRAINER TWELVE DAY

  Patient problems: Blister; Burn(s); Localized Skin Lesion

  MAUDE report 19397378 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS ON BOTH OF THEIR CHEEKS FOLLOWING A THERMAGE FLX TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND 30ML BOTTLE OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 3.0. THE PATIENT RECEIVED TREATMENT TO THEIR FULL FACE. THE PATIENT DID REPORT FEELING SOME PAIN DURING THE TREATMENT HOWEVER THEY SAID THEY WERE ABLE TO TOLERATE IT. NO SYSTEM ERRORS OCCURRED DURING THE PROCEDURE. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED, AND IT WAS INSPECTED PRIOR TO USE AND THROUGH THE TREATMENT EVERY 100 PULSES, WITH NO DISCREPANCIES FOUND. THE PATIENT RETURNED TO THE FACILITY APPROXIMATELY 40 MINUTES FOLLOWING THE PROCEDURE DUE TO OBSERVING BURNS ON BOTH OF THEIR CHEEKS. THE PATIENT WAS PRESCRIBED STEROID INJECTIONS, BURN AREA REGENERATIVE LASERS (OMEGA LIGHTS), DRESSING, AND ANTIBIOTICS. THE PATIENT DID NOT RECEIVE ANY OTHER TREATMENT IN THE SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 30 DAYS PRIOR. THE PATIENT HAD REPORTEDLY RECEIVED BOTOX TREATMENT, ONE TIME IN THE SYMPTOM AREA, IN THEIR PAST PROCEDURE HISTORY. THE PATIENT¿S CURRENT STATUS IS REPORTED AS UNKNOWN. HOWEVER, IT IS NOTED THAT NO PERMANENT SCAR IS EXPECTED. A

  Patient problems: Burn(s); Erythema; Skin Inflammation/ Irritation

  MAUDE report 19263445 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED TREATMENT FOR THEIR BURNS AND RECOVERED WITH NO PERMANENT DAMAGE OR SCARRING. NO DETAILS OF THE BURN TREATMENT WERE PROVIDED. THE SOLTA MEDICAL REVIEWER DETERMINED THAT NO SERIOUS INJURY HAD OCCURRED. THE EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

  Patient problems: Burn(s)

  MAUDE report 18944761 ↗