THERMAGE FLX TG-3ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816995020639), received between Apr 19, 2024 and Apr 19, 2024 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2024Radiation Output Problem; Excessive Heating; Radiation Output Problem; Excessive Heating

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A BURN WITH BLISTERING ON THE LEFT LOWER EYELID DURING A THERMAGE FLX TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER AND ERYTHEMA AND INFLAMMATION WERE VISIBLE ON THE PATIENT''S FACE. IN A SECOND PICTURE PROVIDED, A BLISTER WAS VISIBLE ON THE LOWER EYELID OF ONE EYE. AN EYE SHIELD AND CLOROPH EYE SHIELD LUBRICATION WERE USED. ENCAIN TOPICAL NUMBING CREAM WAS APPLIED TO THE PATIENT. SECONDARY INTERVENTION INCLUDES LUCAS PAPAW/OINTMENT. THE PATIENT''S CURRENT STATUS IS REPORTED THAT THE AFFECTED AREA IS FORMING SCAR TISSUE; HOWEVER, IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE THE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE INCIDENT OCCURRED AFTER 230 SHOTS WITH THE HIGHEST ENERGY OF 2.5 MJ BEING USED. ADDITIONALLY, RADIOFREQUENCY POWER ERRORS, UNDER DELIVER ERRORS, AND TIP TOO WARM ERRORS OCCURRED DURING THE TREATMENT. THE USER TRIED TO REAPPLY THE RETURN PAD WHEN THEY FIRST SAW THE ERROR CODE AND REPLACED IT WITH A NE

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

  MAUDE report 19142952 ↗