Renuvion® APYX-270BPPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607151050061), received between Oct 22, 2021 and Dec 5, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Fracture; Fracture

  THE TIP OF A HANDPIECE BROKE INTRAOPERATIVELY AND REMAINED IN THE PATIENT DURING A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23733249 ↗
• InjuryMar 31, 2022Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED ON (B)(6) 2021 THAT A PATIENT UNDERWENT A COMBINATION PROCEDURE OF VASER LIPOSUCTION, INMODE BODYTITE, AND RENUVION AND SUSTAINED A BURNS TO THE ABDOMEN. THE PATIENT ONLY CONSENTED FOR LIPOSUCTION TO BE PERFORMED DURING THE PROCEDURE. THE INMODE AND RENUVION PRODUCTS WERE USED WITHOUT HER PRIOR CONSENT. THE VASER SETTING WAS 80% AND THE RENUVION SETTING WAS 100% POWER WHICH IS OUTSIDE OF THE RECOMMENDED USE SETTING. NO INFORMATION WAS AVAILABLE ON THE INMODE SETTING USED. HOWEVER, BODYTITE WAS USED TWICE DURING THE PROCEDURE. THE SURGEON WAS UNTRAINED ON THE USE OF THE RENUVION PRODUCT. APYX MEDICAL BECAME AWARE OF THE INCIDENT, BECAUSE THE PATIENT IS A PLASTIC SURGEON WHO IS A USER OF THE RENUVION TECHNOLOGY WHO MENTIONED THE EVENT TO HER SALES REPRESENTATIVE. THE PROCEDURE WAS DONE IN HER OFFICE, WHERE THE RENUVION IS LOCATED. THE PROVIDING PHYSICIAN WAS TOLD NOT TO USE THE SYSTEM. THE BURN WAS CAUSED BY THE DELIVERY OF TOO MUCH ENERGY TO THE ABDOMINAL TISSUE THROUGH THE USE OF MULTIPLE ENERGY DEVICES DURING THE PROCEDURE. THE INVESTIGATION IS INCONCLUSIVE REGARDING WHICH OF THE THREE ENERGY SOURCES CAUSED THE BURN.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 13959211 ↗
• InjuryOct 22, 2021Break; Use of Device Problem; Patient Device Interaction Problem; Break; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO APYX MEDICAL CORPORATION THAT A PLASTIC AND RECONSTRUCTIVE SURGEON WITH MANY YEARS OF EXPERIENCE, WAS PERFORMING A 360° LIPOSUCTION OF THE ABDOMEN FLANK AND INFERIOR BACK, UTILIZING A POWER ASSISTED LIPOSUCTION SYSTEM [ S.A.F.E TECHNIQUE] FOLLOWED BY RENUVION SUB DERMAL SKIN TIGHTENING USING A APYX-270-BPP CM APYX MEDICAL HANDPIECE. DURING THE SECOND PASS AND BEFORE THE THIRD PASS WHILE PERFORMING THE RENUVION TREATMENT, AS THE SURGEON WAS INTRODUCING THE HANDPIECE, HIS THUMB SLIPPED ON THE BUTTON THAT RELEASES THE STAINLESS STEEL BLADE FROM THE HANDPIECE AND WHEN HE PULLED OUT THE HANDPIECE THE BLADE HAD BECOME LODGED INSIDE THE PATIENT'S RIGHT FLANK. TO DATE, NO IMAGES HAVE BEEN PERFORMED AND THE PATIENT IS AWARE OF THE RETAINED BLADE. THE BREAKAGE IS POTENTIALLY FROM HANDLING/TECHNIQUE. HOWEVER, THE PROCEDURE WAS COMPLETED WITH A NEW HANDPIECE AND THE PATIENT IS DOING WELL WITH NO ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12681041 ↗
• InjuryOct 22, 2021Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT LIPOSUCTION AND SUB-DERMAL COAGULATION ON (B)(6) 2021. DURING THE PROCEDURE VASER LIPOSUCTION WAS PERFORMED AT 70% FOLLOWED BY SUB-DERMAL COAGULATION. THE SURGEON PERFORMED MULTIPLE TREATMENT STROKES OVER THE SAME MARKING WHICH WAS IMMEDIATELY STOPPED BY THE APYX MEDICAL CLINICAL REPRESENTATIVE AND WAS EXPLAINED THE RATIONALE THAT THIS DOES NOT ALLOW FOR THERMAL RELAXATION. THE SURGEON HAD PERFORMED 3 STROKES OVER ONE PARTICULAR POINT (ORIGINATING APPROXIMATELY 330/340 DEGREES CRANIAL FROM RIGHT INGUINAL INSERTION SITE WHICH AGAIN THE CLINICAL REPRESENTATIVE HAD ASKED THE SURGEON TO IMMEDIATELY STOP DOING. HOWEVER, WHEN THEY TURNED THE PATIENT THE SURGEON POINTED OUT 3 DARK RED STROKE MARKS ON THE DERMIS WHICH WAS THE EXACT POINT THAT THIS OVER TREATMENT OCCURRED OF WHICH HE WAS INFORMED OF. THE SURGEON PERFORMED 6 PASSES OVER UPPER ABDOMEN FROM LEFT INFRA-MAMMARY INSERTION SITE (NOT CROSSHATCHING). HOWEVER, IT WAS SUGGESTED TO PERFORM LESS DUE TO PREVIOUS COMPLICATIONS AND TO ERR ON THE SIDE OF CAUTION. IT WAS ALSO OBSERVED THAT THE SURGEON WAS NOT USING THE CORRECT CLOCKWISE TECHNIQUE AND SOME STROKES WERE LESS THAN 2 CM APART. HE WAS ALSO

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

  MAUDE report 12681007 ↗