Renuvion APYX-RS3Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607151050115), received between Jul 15, 2022 and Jun 7, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT APPEARED TO EXPERIENCE SUBCUTANEOUS EMPHYSEMA WITH DROP IN PERIPHERAL OXYGEN SATURATION DURING A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT. THE PATIENT APPEARED TO EXPERIENCE SUBCUTANEOUS EMPHYSEMA WITH DROP IN PERIPHERAL OXYGEN SATURATION DURING A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

  Patient problems: Low Oxygen Saturation; Pain; Pneumothorax

  MAUDE report 22162119 ↗
• InjuryMar 3, 2025Self-Activation or Keying; Self-Activation or Keying

  THE PATIENT WAS BURNED BY THE UNPROMPTED ACTIVATION OF AN UNIDENTIFIED MONOPOLAR HANDPIECE DURING A PROCEDURE IN WHICH AN APYX GENERATOR WAS USED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21510528 ↗
• InjuryOct 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT RECEIVED A 3RD DEGREE BURN ON HER NECK.

  Patient problems: Burn(s)

  MAUDE report 17995657 ↗
• InjuryMar 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AN APYX MEDICAL SALES REPRESENTATIVE REPORTED ON 13FEB2023 THAT THEY RECEIVED A REPORT FROM (B)(6) COSMETIC SURGERY INDICATING A PATIENT EXPERIENCED BURNS AFTER A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2022 IN WHICH RENUVION WAS ALSO USED AS PART OF THE OVERALL SURGICAL PROCEDURE. APYX MEDICAL CONTACTED THE OFFICE ON 01MAR2023. THE SURGEON STATED THERE WAS NO DEVICE MALFUNCTION BUT THAT THEY BELIEVE RENUVION, USED IN CONJUNCTION WITH VASER LIPOSUCTION, MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S BURNS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 16601548 ↗
• InjuryJul 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 60 YEAR OLD VERY THIN FEMALE PATIENT WITH NO MEDICAL HISTORY AND NO PREVIOUS PROCEDURES TO THE TREATED AREA UNDERWENT MICRO-AIRE LIPOSUCTION FOLLOWED BY SUBDERMAL COAGULATION WITH RENUVION TO THE SUBMENTAL AREA. THE SURGEON REPORTED A NOTICEABLE BLISTER FORMATION IN THE TREATMENT AREA FOLLOWING 1 TREATMENT PASS OF THE RENUVION DEVICE WITH GENERATOR SETTINGS OF 20% POWER AND 4 LITER PER MINUTES (LPM) OF HELIUM FLOW. UPON DISCOVERY OF THE BLISTER, THE GENERATOR SETTINGS WERE CHANGED TO 60% POWER AND 1.5 LPM OF HELIUM FLOW, AND THE TREATMENT WAS CONTINUED TO BOTH THE RIGHT AND LEFT SIDE OF THE NECK. THE INITIAL GENERATOR SETTINGS OF 20% AND 4 LPM OF THE RENUVION DEVICE WOULD NOT HAVE CONTRIBUTED TO FORMATION OF A BLISTER AFTER ONE TREATMENT PASS AT APPROPRIATE DEVICE TREATMENT SPEEDS. CONTINUING TREATMENT FOLLOWING FORMATION OF A BLISTER IN THE TREATMENT AREA IS NOT RECOMMENDED. THE CAUSE OF THE EVENT IS UNKNOWN AT THIS TIME, BUT CONTINUING TREATMENT FOLLOWING FORMATION OF A BLISTER IN THE TREATMENT AREA IS NOT RECOMMENDED. THE GENERATOR WILL BE SENT BACK TO APYX MEDICAL CORPORATION FOR A FULL EVALUATION.

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

  MAUDE report 15028217 ↗