Fraxel FTX MCSYSFTXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816995027805), received between Jul 25, 2025 and Aug 21, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED HYPERPIGMENTATION AND REDNESS IN THE CHEEK AREA 8 WEEKS POST FRAXEL FTX TREATMENT. APPROXIMATELY FOUR DAYS AFTER A FACIAL AND CHEEK AREA PROCEDURE, THE PATIENT EXPERIENCED NOTICEABLE REDNESS ON THE CHEEKS, WHICH PROGRESSED TO BROWN DISCOLORATION AND DARKENED FURTHER WITHIN 1¿2 WEEKS. THE NATURE OF THE INJURY WAS REPORTED AS POST-INFLAMMATORY HYPERPIGMENTATION/REDNESS. TREATMENT INCLUDED ALASTIN NECTAR AND STRATACEL SCAR GEL. THE CURRENT STATUS WAS REPORTED AS PERSISTENT CHEEK DISCOLORATION WITH A VISIBLE DEMARCATION LINE UNDER THE EYES CORRESPONDING TO THE LASER TREATMENT BOUNDARY. AVAILABLE IMAGES OF THE PATIENT¿S FACE WERE REVIEWED BY THE MEDICAL REVIEWER. A TOTAL OF SEVEN UNDATED IMAGES WAS PROVIDED, SHOWING VARYING VIEWS OF THE PATIENT¿S FACE. SOME OF THESE IMAGES DEPICT MINOR DISCOLORATION ON THE CHEEKBONES AND THE NASAL BRIDGE. THE OUTCOME WAS NOTED AS DISCOLORATION. BASED ON AVAILABLE INFORMATION INDICATING THAT PERMANENT DISCOLORATION IS EXPECTED, THE CASE WAS REASSESSED AS SERIOUS. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE THE SYMPTOMS WERE REPORTED. THE PATIENT HAS HAD PRIOR AESTHETIC TREATMENTS ON

  Patient problems: Erythema; Hyperpigmentation; Skin Discoloration

  MAUDE report 22867159 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED POST INFLAMMATORY HYPERPIGMENTATION AND REDNESS IN THE CHEEK AREA 8 WEEKS POST FRAXEL FTX TREATMENT. A NOTICEABLE PATTERN STARTED RIGHT AWAY THAT WAS VERY RED. THE REDNESS STAYED AND THEN BROWN APPEARED DARKER, MAYBE 1-2 WEEKS POST TREATMENT. TREATMENT INCLUDED ALASTIN NECTAR AND STRATACEL SCAR GEL. THE CURRENT STATUS WAS REPORTED AS PERSISTENT CHEEK DISCOLORATION WITH A VISIBLE DEMARCATION LINE UNDER THE EYES CORRESPONDING TO THE LASER TREATMENT BOUNDARY. THE OUTCOME WAS NOTED AS DISCOLORATION. AVAILABLE IMAGES OF THE PATIENT¿S CHEEKS WERE REVIEWED BY THE MEDICAL REVIEWER. A TOTAL OF FOUR UNDATED IMAGES WERE PROVIDED, DISPLAYING MILD DISCOLORATION ON BOTH CHEEKS. BASED ON AVAILABLE INFORMATION INDICATING THAT PERMANENT DISCOLORATION IS EXPECTED, THE CASE WAS REASSESSED AS SERIOUS. ALL TOPICALS WERE STOPPED 2 WEEKS PRIOR TO THE TREATMENT, WHICH INCLUDED SKIN BETTER ALPHA RET CLEARING AND GLYMED MANDELIC ACID CLEANSER. IMMEDIATELY AFTER THE TREATMENT, ELTA LASER ENZYME GEL WAS USED. POST CARE TOPICALS INCLUDED NECTAR, NEOVA COPPER PEPTIDE MASK, AND NEOVA COPPER PEPTIDE LOTION. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AR

  Patient problems: Erythema; Skin Discoloration; Unintended Loss of Vascular Access

  MAUDE report 22866855 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UPDATED PATIENT STATUS WAS PROVIDED TO SOLTA. THE PATIENT DESCRIBED ONLY ¿VERY MINOR¿ HYPERPIGMENTATION REMAINED IN THE TREATED AREA AND NO PERMANENT SCARRING OR DAMAGE IS EXPECTED. NO SECONDARY INTERVENTION WAS NECESSARY TO TREAT THE INJURY AND ALL LISTED PRODUCTS THE PATIENT USED AFTER TREATMENT, APPEAR TO BE AVAILABLE WITHOUT A PRESCRIPTION AND WERE APPLIED AS PART OF ROUTINE POST-PROCEDURE SKINCARE AT THE TIME OF THE EVENT. AS SUCH, THESE ITEMS DO NOT CONSTITUTE TREATMENT BEYOND STANDARD OF CARE. THE SOLTA MEDICAL REVIEWER HAS REASSESSED THE FILE AND WITH THE NEW INFORMATION HAS DEEMED THE EVENT NOT SERIOUS. AS SUCH, THE EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

  Patient problems: Burn(s); Dry Skin; Erythema; Hyperpigmentation; Pain; Peeling; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 22610700 ↗