Renuvion APYX-27-TPRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607151050160), received between May 14, 2021 and Mar 29, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 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 RIGHT INNER THIGH AFTER MICROAIRE POWER ASSISTED LIPOSUCTION (PAL) WAS PERFORMED AND IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19008336 ↗
• InjuryDec 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A FEMALE PATIENT EXPERIENCED A BURN TO THEIR JAW IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 18260113 ↗
• InjuryOct 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATES PROCEDURE WAS OVER A YEAR AGO. BILATERAL NUMBNESS/TINGLE TO ARMS WRIST TO ARMPIT. NO HAND NUMBNESS. PATIENT STATES SENSATION INTACT TO HANDS.

  Patient problems: Nerve Damage

  MAUDE report 17995649 ↗
• InjuryDec 22, 2022Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  AN APYX MEDICAL SALES REPRESENTATIVE REPORTED ON 01DEC2022 THAT THEY RECEIVED A REPORT FROM DR. KEVIN HANZ OF HANZ AESTHETIC PLASTIC 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 SURGEON ON 15DEC2022. THE SURGEON STATED THERE WAS NO DEVICE MALFUNCTION BUT THAT THEY BELIEVE RENUVION MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S BURNS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 16036357 ↗
• InjuryNov 23, 2022Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED BY DR. MARRERO THAT A PATIENT WAS EXPERIENCING FIBROSIS AFTER A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2022 IN WHICH RENUVION WAS ALSO USED AS PART OF THE OVERALL SURGICAL PROCEDURE. THIS REPORT DID NOT INDICATE WHEN THE PATIENT PRESENTED WITH FIBROSIS. HOWEVER, DR. MARRERO REPORTED THIS ISSUE TO APYX MEDICAL AT FOUR WEEKS POST PROCEDURE. BASED ON THE OR RECORD AND THE PHYSICIAN'S COMMENTS, THE PHYSICIAN ADMITTED THE TRAINING GUIDELINES WERE NOT FOLLOWED AND OVERTREATED THE PATIENT. PATIENT WILL REQUIRE ADDITIONAL SURGICAL TREATMENT FOR THE FIBROSIS. THE SURGEON NOTED THERE WAS NO DEVICE MALFUNCTION.

  Patient problems: Fibrosis

  MAUDE report 15852378 ↗
• InjuryMar 8, 2022Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WITH A HISTORY OF RHINOPLASTY AND BREAST IMPLANTS, UNDERWENT LIPOSUCTION FOLLOWED BY RENUVION TREATMENT. UNDERMINING WAS PERFORMED WITH VIBRASAT PRO AND THERE WERE 2 LITERS OF 1MG OF ADRENALINE INFUSED. 3 PASSES ON ANTEGRADE AND RETROGRADE WERE PERFORMED TO THE ABDOMEN, THIGHS, BACK, ARMS AND BUTTOCKS. 6.5 LITERS OF ASPERATION WAS PERFORMED ON MULTIPLE LOCATIONS FOR 3.5 HOURS. THE PROCEDURE WAS COMPLETED UNEVENTFUL. HOWEVER, THE FOLLOWING DAY, THE PATIENT COMPLAINT OF VIOLENT CHEST AND DORSAL PAIN WHILE SHOWERING. THE PATIENT SUFFERED FROM PAIN FOR FOUR DAYS AND EVENTUALLY FAINTED. THE PATIENT WAS HOSPITALIZED DUE TO PAIN. IT WAS FURTHER DETERMINED THAT THERE WAS ONLY ONE SINGLE INCISION SITE AT THE ARMS WHERE TREATMENT WAS PERFORMED. THE PATIENT WAS SCANNED AND A PNEUMOMEDIASTINUM WAS DIAGNOSED AROUND RIGHT CHEST AND HEART. THERE WAS NO EMBOLISM AND NO OXYGEN COMPROMISE. THE PATIENT WAS ONLY TREATED FOR PAIN. THE PATIENT IS RECOVERING AT HOME. THE LIKELY CAUSE OF THIS INCIDENT IS DUE TO NOT ENOUGH ADEQUATE INCISION SITES FOR GAS EGRESS. IT WAS FURTHER DETERMINED THAT THE SURGEON PERFORMS 3 PASSES AND USES THE LIPOSUCTION CANNULA FOR SUC

  Patient problems: Chest Pain

  MAUDE report 13695868 ↗
• InjuryJan 26, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY DR. (B)(6) THAT HE PERFORMED A SUBDERMAL COAGULATION PROCEDURE WITH THE APYX-27-TP TO THE SUBMENTAL AREA ON (B)(6) 2021. THIS PATIENT HAS NO MEDICAL HISTORY AND NO PREVIOUS PROCEDURES WERE PERFORMED TO THE TREATED AREA. THE GENERATOR SETTINGS WERE AT 60% GAS AND 1.5 LITERS OF FLOW AND FOUR PASSES WERE PERFORMED. THE INSERTION SITES WERE ONE AT EACH INFERIOR EARLOBE AND ONE THE CHIN MIDLINE EACH BIGGER THAN 8 MM. INFILTRATION WAS INFUSED OF 400-450 CC AND A BASKET-TYPE CANNULA WAS USED FOR UNDERMINING. THE RESIDUAL GAS WAS ASPIRATED AFTER THE TREATMENT. POST PROCEDURE THE PATIENT PRESENTED WITH FIBROUS BANDS TO THE TREATED AREA AND IS DISSATISFIED. THE PATIENT HAS HAD A MASSAGE TO THE TREATED AREA AS WELL AS ONE CORTICOSTEROID INJECTION OF TRIAMVIRGI/KENACORT. AN ADDITIONAL INJECTION IS PLANNED IN ONE MONTH. THE SURGEON NOTED THERE WAS NO DEVICE MALFUNCTION.

  Patient problems: Adhesion(s)

  MAUDE report 13359012 ↗
• InjuryOct 22, 2021Use of Incorrect Control/Treatment Settings; Use of Device Problem; Patient Device Interaction Problem; Use of Incorrect Control/Treatment Settings; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT HAD A 360 LIPOSUCTION PROCEDURE TO THE ABDOMEN, FLANKS, LIPO-ABDOMINOPLASTY WITH AN UMBILICAL FLOAT, REPAIR OF DIASTASIS RECTI AND LIPOSUCTION OF TRUNK, MID BACK/BRA ROLL. AND SUBDERMAL COAGULATION ON (B)(6) 2021. IT WAS NOTED THAT THIS WAS THE SURGEON'S FIRST SUB-DERMAL COAGULATION PROCEDURE WITH RENUVION. SUBSEQUENTLY, ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DEHYDRATION AND SEVERE GASTRITIS AS A RESULT OF THE PROCEDURES. UPON ADMISSION TO THE HOSPITAL, THE PATIENT HAD A CT SCAN PERFORMED WHICH SHOWED A LEFT PNEUMOTHORAX AND PNEUMOPERITONEUM. DURING THE PROCEDURE, THE SURGEON RECALLED HITTING A SIGNIFICANT BUMP AGAINST THE SIXTH OR SEVENTH RIB THAT WOULD HAVE RESULTED IN A PENETRATION OF THE POSTERIOR FASCIA AND MUSCULATURE. THE PATIENT DEVELOPED A RETRO-PERITONEAL BLEED REQUIRING A TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS. SUBSEQUENTLY, THE PATIENT DEVELOPED AN INFECTION IN THE RETRO-PERITONEUM REQUIRING A PERCUTANEOUS DRAINING AND INTRAVENOUS ANTIBIOTICS. THE PATIENT IS RECOVERING WELL.

  Patient problems: Pneumothorax; Retroperitoneal Hemorrhage

  MAUDE report 12683862 ↗
• InjurySep 20, 2021Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  IT WAS REPORTED THAT 20 MINUTES INTO A SUBDERMAL COAGULATION PROCEDURE FOLLOWING LIPOSUCTION, THE TIP OF THE HANDPIECE BROKE OFF INSIDE OF THE PATIENT'S LEFT UPPER QUADRANT OF THE ABDOMEN. THE HANDPIECE TIP BROKE IN THE FIRST 3-4 PASSES. THE SURGEON ATTEMPTED TO PALPATE THE TIP UNDER THE SKIN BUT HE COULD NOT FEEL IT AS THE PATIENT HAS A LOT OF FIBROSIS. THE PATIENT WAS THEN SENT FOR AN X-RAY WHICH DID NOT SHOW A FOREIGN BODY. RENUVION TREATMENT WAS COMPLETED WITH ANOTHER CANNULA. A NOTIFICATION WAS SENT TO THE SURGEON THAT THE APR DEVICE USED DURING THE SUBDERMAL COAGULATION PROCEDURE IS MADE OF CERAMIC MATERIALS. THIS TYPE OF MATERIAL IS NOT RADIOPAQUE AND THEREFORE, WOULD NOT SHOW ON A X-RAY. HOWEVER, THE SURGEON DOES NOT BELIEVE THE RETAINED CERAMIC TIP WOULD POSE A HEALTH RISK TO THE PATIENT AND REMAINS INSIDE OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12497741 ↗
• InjurySep 20, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A LETTER WAS RECEIVED FROM A PATIENT WHO UNDERWENT A SUBDERMAL COAGULATION PROCEDURE OF THE BILATERAL INNER, ANTERIOR, OUTER AND POSTERIOR THIGHS AND QWO TO BILATERAL BUTTOCKS ON (B)(6) 2021. POST PROCEDURE, THE PATIENT NOTICED HER LIP WAS SWOLLEN (DUE TO ENDOTRACHEAL TUBE). THREE DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF GAS IN HER CHEST AND NUMBNESS AND CONTINUED SWELLING TO HER LIP WHICH PERSISTED FOR TWO WEEKS. AT THIS TIME THE PATIENT NOTED SHE RETURNED FOR SUTURE REMOVAL AND HAD NOT SEEN ANY IMPROVEMENT TO HER THIGHS YET VISIBLE SIGNS OF "LARGER DIMPLES AND INDENTATIONS" AND WAVES TO HER THIGHS THAT WERE NOT PRE-EXISTING. THE PATIENT ALSO NOTED THAT SHE HAD INFECTIONS AND OPEN SORES TO BOTH INCISION POINTS ON EACH THIGH, SUTURES WERE LEFT IN PLACE AND HER THIGHS WERE BRUISED. ADDITIONALLY, SHE NOTES SHE HAD DARK SPOTS ON HER LEFT BUTTOCK WHERE THE QWO WAS INJECTED. THE PATIENT IS NOW SIX MONTHS POST PROCEDURE AND IS CLAIMING SHE HAS NOT SEEN ANY IMPROVEMENTS IN HER OUTCOME. ON (B)(6) 2021, THIS PATIENT CONSULTED WITH A DIFFERENT A PLASTIC SURGEON WHO NOTED THAT SHE HAS PATCHY DISCOLORATION AND HYPERPIGMENTATION TO AREAS OF HER ANTERIOR-MEDIAL THIGHS POTENTIALLY DUE TO A

  Patient problems: Skin Discoloration

  MAUDE report 12497132 ↗
• InjuryAug 26, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT SUSTAINED BURNS TO THE TRUNK AND BILATERAL FLANK AREAS POST SUBDERMAL COAGULATION PROCEDURE. IT WAS ALSO NOTED THAT THIS WAS THE FIRST TIME THE SURGEON USED RENUVION.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 12369587 ↗
• InjuryJun 3, 2021Use of Device Problem; Patient-Device Incompatibility; Patient Device Interaction Problem; Use of Device Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT SUBDERMAL USE OF THE DEVICE FOLLOWING A LIPOSUCTION PROCEDURE, A PATIENT SUSTAINED A BURN TO THE TREATED AREA. THE PATIENT SUBSEQUENTLY DEVELOPED A BLISTER TO THE TREATED AREA AND UNDERWENT A SKIN GRAFTING PROCEDURE FOR TREATMENT. THIS EVENT REPRESENTS AN OVER TREATMENT AT A PIVOT POINT. THERE WAS NO REPORT OF PERFORMANCE ISSUES WITH THE HANDPIECE OR DELIVERY GENERATOR.

  Patient problems: Blister; Burn(s)

  MAUDE report 11929845 ↗
• InjuryJun 1, 2021Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST RENUVION TREATMENT, A PATIENT HAD RESIDUAL HELIUM RESULTING IN PNEUMOMEDIASTINUM, PNEUMOPERITONEUM, PNEUMOTHORAX REQUIRING HOSPITALIZATION. WITH TOTAL RESOLUTION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND CONTINUES TO DO WELL. THE EVENT WAS NOT RELATED TO THE PERFORMANCE OF THE DEVICE NOR TO A MALFUNCTION OF THE DEVICE, THE DEVICE OPERATED AS INTENDED. RATHER, THE USE OF THE DEVICE OUTSIDE OF ITS GUIDELINES IS THE CAUSE OF THIS EVENT.

  Patient problems: Dyspnea; Headache; Pneumothorax; Vertigo

  MAUDE report 11912143 ↗
• InjuryMay 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE APYX-27-TP HANDPIECE TIP POSSIBLY BROKE INSIDE THE PATIENT DURING A PROCEDURE WITH RENUVION. IT IS UNKNOWN IF THE TIP FELL OFF DURING CLEANING OR DURING THE PROCEDURE AND THE PATIENT HAS NOT BEEN EVALUATED FOR THE PRESENCE OF THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 11827454 ↗