NeuroTherm™ RF-DGP-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067023629), received between Oct 8, 2019 and Dec 9, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Grounding Malfunction” (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 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 9, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY LESIONING PROCEDURE PATIENT EXPERIENCED BURNING SENSATION AT GROUNDING PAD SITE. IN TURN, THE PROCEDURE WAS STOPPED AND GROUNDING PAD WAS REMOVED. RED IRRITATION/ABRASION AT SITE OF GROUNDING PAD WAS NOTED.

  Patient problems: Contact Dermatitis

  MAUDE report 20883829 ↗
• InjuryDec 9, 2024Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE YELLOW COLOR LIKE BURNS ON THEIR SKIN FOLLOWING AN RFA PROCEDURE. THE PATIENT DOES NOT FEEL PAIN AND ANY BURNING SENSATIONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Contact Dermatitis

  MAUDE report 20878855 ↗
• InjuryNov 4, 2022Grounding Malfunction; Overheating of Device; Grounding Malfunction; Overheating of Device

  DURING THE PROCEDURE, THE PATIENT EXPERIENCED A GROUNDING PAD BURN WITH REDDENED SKIN AND BLISTERS. IT WAS NOTED THAT THE PATIENT WAS HAIRY, AND THE AREA WAS NOT SHAVED PRIOR TO PLACEMENT OF THE GROUNDING PAD.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15735451 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RIGHT SIDE SIMPLICITY ABLATION PROCEDURE A SECOND DEGREE PATIENT BURN OCCURRED. FOLLOWING THE PROCEDURE, WHEN THE GROUNDING PAD WAS REMOVED A SECOND DEGREE BURN WAS NOTED ON THE LEFT THIGH WHERE THE PAD WAS LOCATED. THE GROUNDING PAD WAS NOT OVERLAPPING WITH ANY OTHER PAD AND THERE WERE NO WRINKLES OR EDGES LIFTED, HOWEVER; THE PATIENT WAS HAIRY AT THE PAD LOCATION AND THE SKIN WAS NOT PREPPED PRIOR TO PAD PLACEMENT. NO INTERVENTION WAS REQUIRED TO TREAT THE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9167096 ↗