Renuvion APYX-15-TPRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00607151050153), received between Nov 20, 2020 and Apr 25, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Break; Break

  THE PATIENT RECEIVED A FULL THICKNESS BURN ON THE MEDIAL, DISTAL THIGH AND A SEGMENT OF THE HANDPIECE IS BELIEVED TO HAVE BECOME DISLODGED AND WAS RETAINED IN THE PATIENT DURING A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

  Patient problems: Foreign Body In Patient; Full thickness (Third Degree) Burn

  MAUDE report 21913515 ↗
• InjuryFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED WITH SCAR CONTRACTURES AFTER A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

  Patient problems: Scar Tissue; Skin Discoloration

  MAUDE report 21396961 ↗
• InjuryAug 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED WITH A BURN ON THEIR NECK / CHIN / SUBMENTAL AREA 2 WEEKS AFTER A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 19920015 ↗
• InjuryMay 20, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT SUSTAINED A BURN ON THEIR ARM AFTER A SUBDERMAL COAGULATION PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 19353719 ↗
• InjuryMay 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT SUSTAINED A DEEP PARTIAL-THICKNESS (SECOND-DEGREE) BURN WHICH PROGRESSED INTO A FULL-THICKNESS (THIRD-DEGREE) BURN ON THEIR NECK AFTER A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19292107 ↗
• InjuryMar 22, 2024Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  THE PATIENT IS EXPERIENCING HYPER/HYPOPIGMENTATION OF THE NECK APPROXIMATELY SIX MONTHS POST-OPERATIVELY AFTER MICROAIRE POWER ASSISTED LIPOSUCTION (PAL) WAS PERFORMED AND IN WHICH DERMAL RESURFACING WAS PERFORMED WITH A RENUVION HANDPIECE AS PART OF THE OVERALL SURGICAL PROCEDURE.

  Patient problems: Hyperpigmentation; Hypopigmentation

  MAUDE report 18963279 ↗
• InjurySep 24, 2022Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  PATIENT UNDERWENT VASER LIPOSUCTION FOLLOWED BY SUBDERMAL COAGULATION WITH RENUVION TO THE SUBMENTAL AREA. ONE PASS WITH RENUVION WAS PERFORMED AT GENERATOR SETTINGS OF 80% POWER AND 1.5 LITERS OF FLOW. SPEED, SPACING, INFILTRATION SOLUTION AND AMOUNT, TREATMENT PLANE DEPTHS, AND ASPIRATION AMOUNT WAS REQUESTED BUT NOTED AS UNKNOWN BY THE SURGEON'S OFFICE. PATIENT WORE A GARMENT POST PROCEDURE AND FOLLOWED AFTER CARE INSTRUCTIONS PER HER SURGEON'S PROTOCOL. HOWEVER, THREE DAYS POST PROCEDURE, A BURN TO THE TREATED AREA WAS NOTICED. THE DEGREE OF BURN WAS NOT CONFIRMED BY THE SURGEON. MULTIPLE STEROID INJECTIONS OF KENALOG WERE ADMINISTERED BY THE SURGEON TO THE AFFECTED AREA ON (B)(6) 2022. ADDITIONALLY, MICRO-NEEDLING WAS PERFORMED ON (B)(6) 2022 IN EFFORT TO TREAT THE BURN. ALTHOUGH THE SURGEON NOTED THAT THE PATIENT WAS HEALING, THE PATIENT HAS A VISIBLE SCAR POST PROCEDURE AND TREATMENTS AS A RESULT OF THE BURN. THE CAUSE OF THE BURN IS DUE TO END HITS. THE END HITS MAY HAVE BEEN CAUSED BY THE APYX MEDICAL DEVICE OR THE VASER DEVICE OR A COMBINATION OF BOTH DURING THE PROCEDURE. END HITS ARE NOT A RECOMMENDED TECHNIQUE PER THE APYX MEDICAL TECHNIQUE CONSIDERATIONS WHICH ARE DIS

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 15476014 ↗
• InjuryFeb 16, 2022Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY THE SURGEON THAT A (B)(6) YEAR OLD FEMALE PATIENT PRESENTED WITH UNILATERAL MARGINAL MANDIBULAR NERVE INJURY, TWO WEEKS POST LIPOSUCTION AND RENUVION TREATMENT TO THE SUBMENTAL AREA. UNDERMINED WAS PERFORMED IN THE SUBCUTANEOUS PLANE OF THE NECK THROUGH A SUBMENTAL CREASE SMALL INCISION WITH A 3.7MM SINGLE HOLE CANNULA. ABOUT 400 CC OF WETTING SOLUTION WAS INSTILLED AND A TOTAL OF 6 PASSES WERE PERFORMED. POST PROCEDURE, THE PATIENT WAS PLACED IN A COMPRESSION NECK WRAP. THE SURGEON'S MAIN CONCERN WAS TO BE REASSURED THIS WOULD NOT BE PERMANENT. THIS WAS THE SURGEON'S FIRST USE WITH RENUVION. THE PATIENT WILL CONSULT WITH A PLASTIC SURGEON FOR A POSSIBLE INJECTION OF A TOXIN TO THE UNAFFECTED SIDE FOR SYMMETRY UNTIL THE NERVE INJURY IMPROVES. CURRENTLY, THE PATIENT WAS PRESCRIBED AN ORAL STEROID IN EFFORT TO SPEED THE HEALING TIME OF THE NERVE INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 2/14/2022 PROVIDING THE DEVICE INFORMATION, APYX-15-TP, LOT#0000013937. THE SURGEON USED A 3.7 MM SINGLE HOLE CANNULA FOR UNDERMINING, INFILTRATED WITH 400CC OF FLUID. THE LOCATION OF INSERTION SITES WERE AT THE SUBCUTANEOUS PLANE OF THE NECK, THROUGH A SUBMENTAL CREASE INCISIO

  Patient problems: Nerve Damage

  MAUDE report 13545465 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO APYX MEDICAL CORPORATION THAT A PATIENT UNDERWENT A SUPERFICIAL VERSA PROCEDURE FOLLOWED BY SUBDERMAL COAGULATION WITH RENUVION TO THE NECK AND JOWL ON (B)(6) 2021. FOUR PASSES WERE PERFORMED AT 60% POWER AND 1.5L FLOW. SUBSEQUENTLY, THE PATIENT PRESENTED WITH INFLAMMATION AND FEVER. THE PATIENT WAS STARTED ON ANTIBIOTIC THERAPY OF KEFLEX 500 MG TO TREAT THE FEVER AND SWELLING. HOWEVER, THE INFLAMMATION HAS NOT RESOLVED. BASED ON THE REPORTED INFORMATION, THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE. HOWEVER, THE PATIENT DID REQUIRE MEDICAL INTERVENTION.

  Patient problems: Inflammation; Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 12882001 ↗
• InjuryAug 11, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUBDERMAL COAGULATION TRIAL CASE OF UPPER ABDOMEN ONLY. THE PATIENT'S OUTCOME RESULTED IN UPPER ABDOMINAL ADHESIONS DUE TO INAPPROPRIATE USE BY THE SURGEON. THERE WAS NO REPORTED PERFORMANCE ISSUES WITH THE HANDPIECE OR DELIVERY GENERATOR.

  Patient problems: Adhesion(s); Wrinkling

  MAUDE report 12306286 ↗
• InjuryNov 20, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  PATIENT PRESENTED ONE DAY POST-OPERATIVE WITH A THIRD DEGREE BURN. THE INVESTIGATION CONCLUDED THAT THE ISSUE IS ASSOCIATED WITH POOR SURGICAL TECHNIQUE AND POOR PATIENT SELECTION. THERE IS NO REPORTED MALFUNCTION OF THE DEVICE.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 10875134 ↗