FRAXEL MC-SYS-SR1500-D-INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816995027263), received between Mar 28, 2024 and Feb 19, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT EXPERIENCED A BURN ON THE RIGHT FOREHEAD NEAR THE HAIRLINE ONE DAY AFTER A FRAXEL DUAL TREATMENT. THERE WAS NO OVERLAPPING OF PASSES DURING THE TREATMENT. THE TIP HAD BEEN USED ON ONE OTHER PATIENT. A BURN PAPER TEST WAS PERFORMED PRIOR TO THE TREATMENT WITH GOOD RESULTS. FOR 1550, THE HIGHEST ENERGY LEVEL USED/ PERCENT COVERAGE WAS 20/4, WITH 4 PASSES COMPLETED. FOR 1927 THE HIGHEST ENERGY LEVEL USED/ PERCENT COVERAGE WAS 15/2, WITH 4 PASSES COMPLETED. NO SYSTEM ERRORS OR ANYTHING OUT OF THE ORDINARY OCCURRED DURING THE TREATMENT. HOWEVER, WHEN THE EVENT WAS REPORTED EIGHT MONTHS LATER, THE DOCTOR EXPRESSED CONCERNS WITH THEIR FRAXEL SYSTEM REFERENCING A REQUIRED REPAIR AND THIS ADVERSE EVENT THAT OCCURRED DURING SYSTEM TRAINING. THE PATIENT REGULARLY TAKES VITAMIN D AND USES TOPICAL CLEANSER, MOISTURIZER, AND SUNSCREEN. THE PATIENT HAD STOPPED RETINOL AHA/BHA TWO WEEKS PRIOR TO TREATMENT. NO OTHER TREATMENTS WERE BEING PERFORMED IN THE SAME AREA WHERE DEVICE SYMPTOMS WERE REPORTED. THE PATIENT HAD RECEIVED NEUROMODULATORS AND PLATELET-RICH PLASMA APPROXIMATELY TWO MONTHS PRIOR TO TREATMENT. THE PATIENT HAD RECEIVED VENUS VIVA (RADIOFREQUENCY), INTENSE PULSED LIGHT, AND

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 24389998 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT UNDERWENT A FACIAL PROCEDURE AND THE PATIENT EXPERIENCED EDEMA, ABRASION, EXUDATION, AND A HERPES LESION OUTBREAK IN THE PERIORAL REGION 1 DAY POST FRAXEL TREATMENT. ACCORDING TO THE REPORT, THE PATIENT WAS NOT RECEIVING ANY MEDICATIONS AT THE TIME OF THE PROCEDURE AND WAS TREATED WITH PANTHENOL OINTMENT AND FUCICORT CREAM FOLLOWING THE EVENT. THE PATIENT IS CURRENTLY IMPROVING; HOWEVER, RESIDUAL HYPERPIGMENTATION IS ANTICIPATED AS A SEQUELA OF THE EVENT. PHOTOGRAPHS WERE REVIEWED BY THE MEDICAL REVIEWER THAT SHOW LOCALIZED BURNED AREAS ON BOTH SIDES OF THE FACE, WHILE OTHER IMAGES DEPICT NO VISIBLE INJURY. THE IMAGES ARE DATED 1, DAY POST OP, 2 DAYS POST OP, 3 DAYS POST OP AND 4 DAYS POST OP. THE PATIENT HAS BEEN INSTRUCTED WITH STRICT AVOIDANCE OF UV EXPOSURE. THE PATIENT EXPERIENCED PAIN EVEN AT A LOW ENERGY LEVEL. THE SKIN TYPE RECORDED FOR THE PATIENT IS TYPE III. THE HIGHEST ENERGY USED WAS 20, WITH 4 PASSES, AT A TREATMENT LEVEL OF 4. THE TREATMENT TIP HAS BEEN USED 3 TIMES ON PREVIOUS PATIENTS. A BURN PAPER TEST WAS NOT PERFORMED PRIOR TO USING THE TIP. IT IS REPORTED THAT THE INCIDENT OCCURRED ON THE FIRST REP. DUE TO THE REPORTED OU

  Patient problems: Abrasion; Burn(s); Hyperpigmentation; Pain; Swelling/ Edema; Viral Infection

  MAUDE report 23900855 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED INFORMATION OF DATED PICTURES DEMONSTRATES THE FIRST PHOTOGRAPH SHOWING BLISTER FORMATION WAS TAKEN ON THE SAME DAY AS THE TREATMENT. THREE ADDITIONAL PHOTOGRAPHS WERE TAKEN 2 DAYS POST TREATMENT AT THE TIME OF THIS REPORT. THE PATIENT¿S CONDITION WAS REPORTED AS IMPROVING. THERE IS A POTENTIAL FOR RESIDUAL HYPERPIGMENTATION.

  Patient problems: Blister; Burn(s); Hyperpigmentation; Pain

  MAUDE report 23900839 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S STATUS 57 DAYS POST-PROCEDURE IS THE PATIENT HAS NO SCARRING OR PERMANENT DAMAGE BUT STILL HAS POST INFLAMMATORY PIGMENTATION WITH SOME MELASMA AND FRECKLES. THE PATIENT'S CURRENT STATUS 80 DAYS POST-PROCEDURE, IS THAT THERE IS POST INFLAMMATORY PIGMENT AND UNDERLYING RED/INFLAMMATION. THE PATIENT IS IMPROVING AND ON HORMONE REPLACEMENT THERAPY. THE PIGMENTATION IS LESS NOTICEABLE, BUT THEY DO HAVE MELASMA. THE PATIENT IS STILL HEALING WITH NO SCARRING.

  Patient problems: Burn(s); Erythema; Hyperpigmentation; Nodule; Pain; Skin Discoloration; Sleep Dysfunction; Viral Infection

  MAUDE report 21867437 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PATIENT IS "GOOD AGAIN (HEALED)" AND THE EVENT IS RESOLVED. THE INFORMATION PROVIDED DOES NOT SUGGEST THIS INCIDENT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, SERIOUS INJURY OR A SERIOUS DETERIORATION IN STATE OF HEALTH. THIS EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

  Patient problems: Blister

  MAUDE report 18997226 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PATIENT IS "GOOD AGAIN (HEALED)" AND THE EVENT IS RESOLVED. THE INFORMATION PROVIDED DOES NOT SUGGEST THIS INCIDENT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, SERIOUS INJURY OR A SERIOUS DETERIORATION IN STATE OF HEALTH. THIS EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

  Patient problems: Blister

  MAUDE report 18991266 ↗