Thermage TTNS3.00E4-900Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00850608002445), received between Jan 11, 2024 and Jun 16, 2025 — classified as 7 injuries, 2 malfunctions.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED A BLISTER ON THE LEFT SIDE OF THE FOREHEAD A DAY AFTER RECEIVING A THERMAGE CPT TREATMENT OF THE FACE AND NECK. IT WAS REPORTED THAT THE PATIENT WAS SEDATED WITH NITROUS OXIDE TO COMPLETE THE TREATMENT. NO SECONDARY INTERVENTIONS WERE PROVIDED TO THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT¿S CURRENT STATUS AND THE POSSIBILITY OF ANY PERMANENT DAMAGE OR SCARRING REMAINS UNKNOWN. THE UNUSED TREATMENT TIP WAS NOT INSPECTED PRIOR TO STARTING OR THROUGHOUT THE PROCEDURE. ACCORDING TO THE REPORTER, DURING THE TREATMENT TWO ERROR MESSAGES WERE RECEIVED INDICATING THAT TUNING WAS NEEDED. THE HIGHEST ENERGY USED WAS 3MJ, USING THE STAMPING METHOD. THE USER FACILITY CONFIRMED USING SOLTA CRYOGEN AND COUPLING FLUID TO COMPLETE THE TREATMENT; A GEL APPLICATION WAS APPLIED PER ROW. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAD NO HISTORY OF AESTHETIC TREATMENTS. NO ADDITIONAL INFORMATION IS ABLE TO BE RECEIVED FROM THE PATIENT, AS THE CLINIC HAS BEEN UNABLE TO CONTACT THEM. NO PATIENT PHOTOS ARE AVAILABLE TO BE REVIEWED. THE TREATMENT TIP WAS DISCARDED BY THE USER FACILITY; THEREFORE

  Patient problems: Blister

  MAUDE report 22216591 ↗
• InjuryJun 16, 2025Misconnection; Misconnection

  THE USER FACILITY REPORTED A BLISTER ON THE LEFT CHEEK THAT WAS NOTICED THE DAY AFTER RECEIVING A THERMAGE CPT TREATMENT OF THE CHEEKS, CHIN, AND FOREHEAD. IT WAS REPORTED THAT THE PATIENT WAS SEDATED WITH NITROUS OXIDE TO COMPLETE THE TREATMENT. NO SECONDARY INTERVENTIONS WERE PROVIDED TO THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT¿S CURRENT STATUS AND THE POSSIBILITY OF ANY PERMANENT DAMAGE OR SCARRING REMAINS UNKNOWN. THE UNUSED TREATMENT TIP WAS NOT INSPECTED PRIOR TO STARTING OR THROUGHOUT THE PROCEDURE; DURING THE PROCEDURE A, "PLEASE CHECK THE CONNECTION BETWEEN THE PAD AND THE CARTRIDGE¿ ERROR MESSAGE WAS PROMPTED. IT IS UNKNOWN DURING WHAT REP THE ERROR WAS DISPLAYED. THE HIGHEST ENERGY USED WAS 3MJ, USING THE STAMPING METHOD. THE USER FACILITY CONFIRMED USING SOLTA CRYOGEN AND APPROXIMATELY HALF A BOTTLE OF SOLTA COUPLING FLUID TO COMPLETE THE TREATMENT. THE PATIENT HAS A HISTORY OF UNDERGOING UNSPECIFIED THERMAGE TREATMENTS IN THE SAME SYMPTOM AREA; HOWEVER, THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. NO ADDITIONAL INFORMATION IS ABLE TO BE RECEIVED FROM THE PATIENT, AS THE CLINIC HAS BEEN UNABLE TO CONTACT

  Patient problems: Blister

  MAUDE report 22216578 ↗
• MalfunctionJan 28, 2025Material Discolored; Material Discolored

  A USER FACILITY REPORTED THAT THERE WAS A DARK SPOT ON THE THERMAGE CPT TIP MEMBRANE FOUND DURING A TREATMENT. A REPLACEMENT TIP WAS USED FOR THE REMAINDER OF THE PATIENT TREATMENT AND THE DAMAGED TIP WAS RETURNED FOR EVALUATION. NO DETAILS WERE PROVIDED FOR THE PATIENT TREATMENT AND THERE WAS NO INJURY REPORTED. DEPOT EVALUATED THE TREATMENT TIP AND CONFIRMED THE DARK SPOT WAS DIELECTRIC BREAKDOWN OF THE TIP MEMBRANE. THIS EVENT MEETS REPORTABILITY REQUIREMENTS AS IT IS A REPORTABLE MALFUNCTION PER SOLTA PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256358 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED A BLISTER TO THE LEFT SIDE OF THE JAW DURING A THERMAGE CPT TREATMENT. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDED GENTICIN CREAM, BENTAZONE CREAM, AND WHITE PETROLEUM JELLY. THE PATIENT'S CURRENT STATUS IS REPORTED AS "TEAR THE BLISTER". THE PATIENT HAS NOT RETURNED TO THE CLINIC, AND UNABLE TO CONFIRM PATIENT OUTCOME. NO PHOTOGRAPHS ARE AVAILABLE. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. NOR HAS THE PATIENT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE HIGHEST ENERGY LEVEL USED WAS 1.5J. NO SYSTEM ERRORS OCCURRED, NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND THERE WAS NOTHING REMARKABLE TO NOTE. THE TREATMENT TIP SURFACE WAS INSPECTED DURING THE TREATMENT EVERY 50 PULSES. THIS IS THE FIRST TIME THE TIP WAS USED.

  Patient problems: Blister

  MAUDE report 21178823 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATMENT WAS CONDUCTED NORMALLY, AND NO EQUIPMENT MALFUNCTIONS WERE REPORTED. THE PATIENT HAS REPORTEDLY FULLY RECOVERED. THE EVENT REMAINS CLASSIFIED AS SERIOUS BY THE SOLTA MEDICAL REVIEWER DUE TO THE PATIENT'S NEED FOR OPHTHALMOLOGIC EVALUATION BY A SECOND PHYSICIAN, WHICH IS OUTSIDE STANDARD OF CARE.

  Patient problems: Blister; Burn(s); Conjunctival Hemorrhage

  MAUDE report 20795858 ↗
• 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 REDNESS AND POTENTIAL BURNS ON THEIR FOREHEAD AFTER A THERMAGE CPT TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND APPROXIMATELY 30-40CC OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 4.0. THE PATIENT RECEIVED TREATMENT TO THEIR FACE AND AROUND THE 3RD PASS WITH 110-130 SHOTS DELIVERED, IT WAS OBSERVED THERE WAS SOME REDNESS AND POSSIBLE BURNS OR FREEZE BURNS ON THEIR FOREHEAD. NO SYSTEM ERRORS OR EQUIPMENT ISSUES OCCURRED DURING THE PROCEDURE. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED ON A PATIENT, AND IT WAS INSPECTED PRIOR TO THE PROCEDURE AND EVERY 50 PULSES THROUGHOUT, WITH NO DISCREPANCIES FOUND. THE PATIENT WAS GIVEN DERMOSOL AND PREDNISOLONE TO TREAT THE INJURY. THEY HAD NOT RECEIVED ANY OTHER TREATMENT IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT DID RECEIVE BOTOX TREATMENT TO THEIR FOREHEAD IN THE PAST. THEIR CURRENT STATUS IS THAT THERE IS REDNESS AND IT¿S UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING.

  Patient problems: Burn(s); Erythema

  MAUDE report 20759624 ↗
• InjurySep 18, 2024Improper or Incorrect Procedure or Method; Excessive Heating; Improper or Incorrect Procedure or Method; Excessive Heating

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED SECOND DEGREE BURNS TO THE RIGHT CHEEK THE DAY AFTER A THERMAGE CPT TREATMENT OF THE FACE AND NECK. THE INCIDENT OCCURRED ON THE LAST 130 REPS, WITH FACIAL LESIONS WERE OBSERVED AT AROUND 800 REPS. THE HIGHEST ENERGY LEVEL USED WAS 2.5. EXCESSIVE FORCE AND TIP TOO WARM ERRORS OCCURRED DURING THE TREATMENT. SOLTA MEDICAL CRYOGEN AND APPROXIMATELY ¾ BOTTLE OF COUPLING FLUID WERE USED DURING THE TREATMENT. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE AND WHEN LESIONS WERE NOTED ON THE PATIENT¿S FACE, WITH NOTHING ATYPICAL OBSERVED ON THE TIP. THIS WAS THE INITIAL USE OF THE TREATMENT TIP. THE THERMAGE CPT TREATMENT WAS PERFORMED IN CONJUNCTION WITH ULTHERAPHY, BOTOX MASSETER, AND LUXURY FACIAL. THE PATIENT ALSO HAD A LUXURY FACIAL, COQUILLE PEEL, AND LUSTRII LASER SEVENTEEN DAYS PRIOR TO THE THERMAGE CPT TREATMENT. THE PATIENT HAS A PRIOR HISTORY OF MONTHLY FACIALS. SECONDARY INTERVENTION AS A RESULT OF THE BURNS INCLUDED EMOLLIENT FACE WASH TWICE A DAY, BETA+CENTA TWICE A DAY FOR SEVEN DAYS. EMOLLIENT CREAM AND SUNSCREEN ONCE A DAY IN THE MORNING. EMOLLIENT OINTMENT ONCE A DAY AT NIGHT. TEN DAYS AFTER TREATMENT, THE PATIENT REPORTED

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

  MAUDE report 20250667 ↗
• MalfunctionMay 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A USER FACILITY REPORTED BURNS TO THE PATIENT¿S FACE DURING A THERMAGE CPT FACIAL TREATMENT. THERE WERE MORE THAN 200 SKIN EPIDERMAL BREAKS ON THE LEFT SIDE OF THE PATIENT'S FACE, WITH A DIAMETER OF 1-3 MM. DURING THE TREATMENT, THE CONSUMER REPORTEDLY FELT SLIGHTLY MORE TINGLING SENSATION ON THE LEFT SIDE COMPARING TO RIGHT SIDE. UPON CHECKING THE TIP, THE PROVIDER FOUND THAT THE TIP WAS OBVIOUSLY DAMAGED. THERE WERE REPORTEDLY SMALL BLACK LESIONS ON THE SIDE OF THE TREATMENT HEAD, WITH A DIAMETER OF ABOUT 1-2MM. SURFACE ANESTHESIA WAS USED DURING THE TREATMENT. NO OTHER TREATMENTS HAD BEEN PERFORMED IN THE SAME SYMPTOM AREA WITHIN THE PRIOR THIRTY DAYS. THE EVENT OCCURRED AT APPROXIMATELY 200 REPS. THE HIGHEST ENERGY USED WAS 4-5.5. SOLTA MEDICAL CRYOGEN AND ENOUGH COUPLING FLUID WAS USED DURING THE TREATMENT. THE TIP WAS NOT INSPECTED PRIOR TO TREATMENT, BUT WAS INSPECTED EVERY 100 REPS. THE DOCTOR TOLD THE CONSUMER TO COMPRESS FOR 30 MINUTES IMMEDIATELY AFTER THE TREATMENT. ERYTHROMYCIN EYE OINTMENT WAS PROVIDED TO PREVENT INFECTION. EPIDERMAL GROWTH FACTOR AND MEDICAL COLD COMPRESS WERE USED. THE PATIENT EXHIBITED LOCAL SKIN DAMAGE AND SCABBING, WITH NO SERIOUS SEQUELA. THERE

  Patient problems: Burn(s)

  MAUDE report 19273102 ↗
• InjuryJan 11, 2024Overheating of Device; Overheating of Device

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BLISTERS AND SECONDARY THERMAL BURNS FOLLOWING A THERMAGE CPT TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND APPROXIMATELY ONE BOTTLE OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 1.5. THE PATIENT RECEIVED TREATMENT ON THEIR FACE AND NECK. AROUND 600 PULSES, THE SYSTEM GAVE A WARNING THE MAXIMUM TIP TEMPERATURE HAD BEEN REACHED. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE, AND DURING THE TREATMENT, HOWEVER IT'S UNKNOWN HOW FREQUENTLY IT WAS CHECKED DURING USE. AFTER THE TREATMENT IN THE EVENING, THE PATIENT REPORTEDLY OBSERVED BLISTERS A SECONDARY THERMAL BURN ON THE LEFT SIDE OF THEIR NECK. THE PATIENT WAS PRESCRIBED STEROIDS WITH ANTIBIOTICS AS A RESULTS OF THIS EVENT. NO OTHER PROCEDURES WERE PERFORMED IN THE SAME SYMPTOM AREA ON THE DAY OF THE PROCEDURE. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY OTHER PROCEDURES OR AESTHETIC TREATMENTS WITHIN 90 DAYS OF THIS TREATMENT OR ANYTIME IN THEIR PAST HISTORY IN THE SAME SYMPTOM AREA. THE PATIENT'S CURRENT OUTCOME IS UNKNOWN AT THIS TIME. A SOLTA MEDICAL REVIEWER EXAMINED PHOTOS OF THE PATIENT INJURY. POST INFLAMMATORY HYPERPIGMENTATION WAS VISIBLE MOSTLY ON ONE SIDE

  Patient problems: Blister; Burn(s); Hyperpigmentation

  MAUDE report 18499380 ↗