Renuvion®/J-Plasma® APYX-270BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607151050016), received between May 11, 2022 and May 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMay 11, 2022Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  A (B)(6) FEMALE PATIENT WITH MEDICAL HISTORY OF CHRONIC PULMONARY OBSTRUCTIVE DISEASE (COPD) SECONDARY TO SMOKING, UNDERWENT A RENUVION PROCEDURE ON (B)(6) 2022, WHICH TOOK PLACE (B)(6). THE SURGERY WAS PERFORMED USING THE APYX-270B WITH GENERATOR SETTINGS AT 70% POWER AND 3 LITERS OF FLOW PER MINUTE UNDER GENERAL ANESTHESIA WITH ORAL TRACHEAL INTUBATION. ACCUMULATION OF HELIUM GAS DURING THE PROCEDURE WAS MASSAGED AND SUCTIONED AT THE END OF THE PROCEDURE WITH SOME IMPROVEMENT AND THE PATIENT WAS DISCHARGED HOME. SUBSEQUENTLY, THE PATIENT SUFFERED RESPIRATORY DISTRESS RESULTING IN EXTENSIVE SUBCUTANEOUS EMPHYSEMA (FACE, NECK, ARMS, BACK, ABDOMEN AND THIGHS), MARGINAL RIGHT PNEUMOTHORAX AND COMPLETE LEFT PNEUMOTHORAX DIAGNOSE BY A CT-SCAN. THE PATIENT WAS ADMITTED TO A HOSPITAL INTENSIVE CARE UNIT AND WAS TREATED WITH A CHEST TUBE TO THE LEFT LUNG. FURTHER REVIEW BY THE APYX MEDICAL ADVISORY BOARD DETERMINED THE FOLLOWING: IMPROPER TUNNELING WAS PERFORMED PRIOR TO USE OF THE RENUVION HANDPIECE. INSUFFICIENT NUMBER OF PORTALS AND THEIR INTERCONNECTION TO FACILITATE THE EVACUATION OF GASES DURING THE PROCEDURE. HIGH GAS FLOW CONFIGURATION (3 LITERS PER MINUTE IN ALL TREATED AREAS). F

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Pneumothorax

  MAUDE report 14360199 ↗