NA RFG-4-120VRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729968313), received between Mar 2, 2019 and Feb 27, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 27, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXHIBITED A BURN NEAR THE NEEDLE SITE DURING THE PROCEDURE. IT WAS NOTED THAT THE RADIOFREQUENCY GENERATOR STARTED SMOKING.

  Patient problems: Burn(s)

  MAUDE report 16441965 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A BURN ON PATIENTS SKIN. THE BLISTER WAS NOTICED AFTER THE GROUNDING PAD WAS REMOVED. IT WAS REPORTED THAT THE APPLICATION SITE WAS NOT CLEAN AND THE GROUNDING PAD WAS APPLIED POSTERIOR TO THE RIGHT THIGH. THE PATIENT WAS PROVIDED SILVADENE OINTMENT AND THE PATIENTS BLISTER WAS HEALING APPROPRIATELY.

  Patient problems: Burn(s)

  MAUDE report 15734221 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A MILD BACTERIAL INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL. NO FURTHER DETAILS HAVE BEEN REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 13664844 ↗
• InjuryJan 6, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT HAD A BURN FROM THE GROUNDING PAD SITE.

  Patient problems: Burn(s)

  MAUDE report 13175655 ↗
• InjuryMar 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS SHOCKED DURING AN RF ABLATION PROCEDURE.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 8384242 ↗