Thermage TTNS0.25NB1-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850608002278), received between Feb 6, 2024 and Jan 23, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Sparking” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT THEY HAD RECEIVED THERMAGE CPT TREATMENT AT A USER FACILITY AND EXPERIENCED SECOND-DEGREE BURNS AND BLISTERS ON THEIR UPPER AND LOWER EYELID AREAS ON BOTH EYES. PRIOR TO TREATMENT, THE PHYSICIAN SUSPECTED XANTHELASMA IN THE RIGHT UPPER EYELID REGION. THE PATIENT HAD RECEIVED PREVIOUS AESTHETIC TREATMENTS AND PERIOCULAR COSMETIC PROCEDURES IN THE SAME TREATMENT AREAS, INCLUDING FILLER INJECTIONS (AVELANE) IN THE LOWER EYELID WHICH RESULTED IN VASCULAR OCCLUSION AND BRUISING OF THE LEFT EYE AT THE TIME. THE PATIENT ALSO RECEIVED ROUTINE RADIO-FREQUENCY BASED SKIN TIGHTENING TREATMENTS. DUE TO THE PATIENT¿S HISTORY, THE PHYSICIAN TOOK A CAUTIOUS TREATMENT APPROACH DURING THE THERMAGE CPT TREATMENT. INITIAL EYE ENERGY WAS SET AT 2.0. ENERGY SETTINGS RANGED FROM 2.5¿3.5 FOR THE UPPER EYELID, 2.5¿3.0 FOR THE LOWER EYELID, AND 1.5¿2.0 FOR THE MEDIAL CANTHUS AND OTHER SENSITIVE AREAS. APPROXIMATELY 225 PULSES WERE DELIVERED TO EACH EYE AREA WITH 150-160 PULSES DELIVERED TO THE UPPER EYE LID AREAS. TREATMENT OF THE RIGHT EYE WAS COMPLETED PRIOR TO INITIATION OF TREATMENT ON THE LEFT EYE. NO ABNORMALITIES WERE OBSERVED BY THE PHYSICIAN DURING TREATMENT. THE PATIENT RE

  Patient problems: Blister; Erythema; Pain; Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 24162045 ↗
• InjurySep 26, 2025Energy Output Problem; Energy Output Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A SECOND-DEGREE BURN INVOLVING THE UPPER AND LOWER EYELIDS FOLLOWING A THERMAGE CPT EYE PROCEDURE. A SUPERFICIAL ANESTHETIC CREAM, SINCAINE 5%, WAS APPLIED PRIOR TO THE BEGINNING OF THE TREATMENT, HOWEVER THE PATIENT REPORTEDLY WAS ALERT AND ABLE TO PROVIDE FEEDBACK DURING THE PROCEDURE. EYE SHIELDS WERE PLACED IN BOTH EYES, AND THE PATIENT WAS GIVEN ANESTHETIC EYE DROPS. DURING TREATMENT AT APPROXIMATELY 100-125 PULSES, THE PROVIDER OBSERVED THE PATIENT¿S SKIN WAS VERY RED BUT THE PATIENT ADVISED THEM THEIR SKIN TURNS RED EASILY. THE PATIENT RECEIVED TOPICAL OINTMENT, HYPERBARIC OXYGEN THERAPY, AND PICOSECOND LASER TREATMENT FOR THE INJURY. ADDITIONALLY, THE PATIENT APPLIED SILVERZINE CREAM AND ICE AT HOME. THE PATIENT¿S STATUS IS THE BLISTER HAD RUPTURED, HOWEVER, IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. THE PROVIDER STATED THE CASE HAD BEEN HANDED OVER TO THEIR INSURANCE COMPANY AND THEY DO NOT WISH TO COMMENT ANY FURTHER ON THE PATIENT¿S RECOVERY STATUS. NO OTHER TREATMENTS WERE PERFORMED IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT HAD RECEIVED AN UNKNOWN AESTHETI

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

  MAUDE report 23157660 ↗
• MalfunctionJul 29, 2025Sparking; Excessive Heating; Sparking; Excessive Heating

  THE USER FACILITY REPORTED A MAXIMUM TEMPERATURE REACHED EVENT CODE AND A FLASHING LIGHT THAT APPEARED AT THE END OF THE TREATMENT TIP AFTER STARTING A THERMAGE CPT TREATMENT. THERE WAS NO INJURY TO THE PATIENT, THE PROCEDURE WAS RESUMED AFTER REMOVING THE AFFECTED TREATMENT TIP AND PLACING A NEW ONE. THE TREATMENT TIP WAS RETURNED TO SOLTA FOR AN EVALUATION AND DIELECTRIC BREAKDOWN WAS OBSERVED; THEREFORE, THIS MEETS THE REPORTABILITY REQUIREMENTS FOR A MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22654515 ↗
• InjuryFeb 21, 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 AND BLISTERS ON THEIR EYE AREA FOLLOWING A THERMAE CPT TREATMENT. SOLTA MEDICAL BRANDED CRYOGEN AND TWO BOTTLES OF COUPLING FLUID WAS USED WITH THE HIGHEST LEVEL OF TREATMENT AT 4.0. PRIOR TO THE PROCEDURE THE PATIENT WAS ADMINISTERED DORMICUM AS AN ANESTHETIC. EYE SHIELDS WERE INSERTED AND TREATMENT WAS DELIVERED TO THE PATIENT'S EYE AREAS. NO SYSTEM ERRORS OCCURRED DURING THE TREATMENT. THIS IS THE FIRST TIME THE TREATMENT TIP HAS BEEN USED AND IT WAS INSPECTED PRIOR TO TREATMENT WITH NO DISCREPANCIES FOUND. THE TIP WAS NOT INSPECTED AGAIN THROUGHOUT THE PROCEDURE. THE DAY FOLLOWING THE PROCEDURE THE PATIENT OBSERVED BURNS AND BLISTERS AROUND ONE EYE. THE PATIENT HAD NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE OR WITHIN 90 DAYS PRIOR. THE PATIENT DID RECEIVE BTL EXILIS RADIO-FREQUENCY TREATMENT TO THE SYMPTOM AREA ON OCTOBER 7, 2023. THE PATIENT¿S CURRENT OUTCOME IS NOT KNOWN AT THIS TIME. A SOLTA MEDICAL REVIEWER EXAMINED PHOTOS OF THE PATIENT INJURY. ONE PICTURE SHOWED CRUSTING UNDER THE EYE AND HYPERPIGMENTED AREAS AROUND THE EYE. THE SECOND PICTURE SHOWED AN OPEN BLISTER UNDER THE

  Patient problems: Blister; Burn(s); Hyperpigmentation

  MAUDE report 18753922 ↗
• MalfunctionFeb 6, 2024Material Puncture/Hole; Sparking; Material Puncture/Hole; Sparking

  ADDITIONAL INFORMATION INCLUDES THE FOLLOWING: ALL JEWELRY OR BODY PIERCINGS IN THE TREATMENT AREA REMOVED PRIOR TO THE TREATMENT. THE PATIENT WAS ALERT AND ABLE TO PROVIDE FEEDBACK TO THE CLINICIAN DURING THE PROCEDURE. THE SKIN WAS FLAT DURING TREATMENT; AND THE PROVIDER WAS ABLE TO MAINTAIN GOOD CONTACT THROUGHOUT TREATMENT. THE PATIENT DID NOT APPLY ANYTHING OVER THE COUNTER AT HOME TO TREAT THE BURN.

  Patient problems: Blister

  MAUDE report 18650127 ↗