xeoRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816722021106), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (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.

• InjuryDec 4, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  INFORMATION FROM TREATING CLINIC ((B)(6) 2025): AFTER MULTIPLE REQUESTS FOR INFORMATION, DR. OLIVO'S OFFICE INFORMED CUTERA THAT THE PATIENT SUSTAINED A ~0.5-INCH BURN ON THE MIDLINE CHEST AND A ~1-INCH BURN ON THE GLUTEAL CLEFT. THE CLINIC REPORTED THAT THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. CUTERA WAS NOT NOTIFIED OF THESE INJURIES AT THE TIME OF OCCURRENCE IN (B)(6) 2025. CUTERA FIRST BECAUSE AWARE OF THE EVENT THROUGH THE MDR SUBMITTED DIRECTLY TO THE FDA BY THE PATIENT (MW5175595). FOLLOW-UP MEDICAL CARE (PER PATIENT REPORT): THE PATIENT STATED THAT SHE RECEIVED WOULD CARE AND SCAR MANAGEMENT AT A BURN CENTER UNDER THE CARE OF A PLASTIC SURGEON. REPORTED MANAGEMENT INCLUDED APPLICATION OF SILVER SULFADIAZINE CREAM TWICE DAILY, USE OF NON-STICK DRESSINGS, MONITORING FOR SIGNS OF INFECTION, AND ONGOING FOLLOW-UP FOR POTENTIAL HYPERTROPHIC OR KELOID SCARRING. ROOT CAUSE ASSESSMENT: THE DEVICE OPERATOR REPORTEDLY USED THE MAXIMUM RECOMMENDED FLUENCE (12 J/CM^2) IN COMBINATION WITH A REPETITION RATE ABOVE THE RECOMMENDED RANGE (10 HZ VERSUS THE RECOMMENDED 4-8 HZ). THIS COMBINATION LIKELY CONTRIBUTED TO EXCESSIVE THERMAL ACCUMULATION WITHIN THE SMALL TREATMENT AREA, RESULTING

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 23723084 ↗