FRACTORA AG601261ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290016633054), received between Aug 27, 2023 and Aug 30, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  BURNS ON FACE WITH SUBSEQUENT CONTAMINATION. RESIDUAL INDENTATIONS 3 MONTHS POST TREATMENT.

  Patient problems: Burn(s); Scar Tissue; Skin Infection

  MAUDE report 17648619 ↗
• InjuryAug 29, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  PIH ON FACE AND FOOTPRINT MARKS OVER THE NECK 2 MONTHS POST TREATMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hyperpigmentation

  MAUDE report 17641839 ↗
• InjuryAug 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS COMPLAINT WAS INITIALLY REPORTED BY THE PATIENT DIRECTLY TO FDA ON (B)(6) 2020 (MW5101332) AND STATED: "HAD A FRACTORA PROCEDURE DONE WHICH RESULTED IN PERMANENT SCARRING ON MY FACE.".

  Patient problems: Scar Tissue

  MAUDE report 17639789 ↗
• InjuryAug 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS COMPLAINT WAS INITIALLY REPORTED BY THE PATIENT DIRECTLY TO FDA ON (B)(6) 2020 (MW5097418) AND STATED " I HAD FRACTORA RF MICRONEEDLING AT MY PLACE OF WORK. IT RESULTED IN SCARRING, FAT LOSS AND ELASTICITY LOSS IN MY FACE. IT ALSO HAD A HUGE IMPACT ON ME PSYCHOLOGICALLY RESULTING IN PTSTD. FDA SAFETY REPORT ID# (B)(4). "

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Scar Tissue

  MAUDE report 17628884 ↗