NT1100™ RFG-NT-1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 05415067022370), received between Jun 15, 2018 and Jul 23, 2025 — classified as 76 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE REGENERATOR WAS UNABLE TO DETECT ANY PROBES AND THE PROCEDURE WAS ABANDONED. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583628 ↗
• InjuryNov 1, 2024No Tactile Prompts/Feedback; No Tactile Prompts/Feedback

  IT WAS REPORTED THAT THE GENERATOR'S TOUCHSCREEN WAS UNCALIBRATED DURING A PROCEDURE. AS A RESULT, THE PROCEDURE WAS ABANDONED AND THE PHYSICIAN PERFORMED AN OPIOID INFILTRATION INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588053 ↗
• InjuryJul 1, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A RADIO FREQUENCY ABLATION, THE GENERATOR FAILED TO PRODUCE THE REQUIRED OUTPUT NECESSARY FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652503 ↗
• InjurySep 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT DURING AN ABLATION PROCEDURE. AS A RESULT, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS FOR AN EXTENDED PERIOD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17669051 ↗
• MalfunctionMar 13, 2023Failure to Deliver Energy; Failure to Deliver Energy

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE VOLTAGE WAS NOT REACHING TARGETED LEVEL. AS A RESULT, THE PROCEDURE COULD NOT BE COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530422 ↗
• MalfunctionFeb 16, 2023Insufficient Heating; Insufficient Heating

  DURING THE PROCEDURE, THE GENERATOR DID NOT REACH SET TARGET TEMPERATURE. AS A RESULT, THE PROCEDURE COULD NOT BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16391899 ↗
• InjuryFeb 14, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE VOLTAGE ON THE SENSORY AND MOTOR TESTING WOULD NOT GO ABOVE 0.01. TROUBLESHOOTING WAS ATTEMPTED, BUT UNSUCCESSFUL. AS A RESULT, THE PROCEDURE WAS ABANDONED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376283 ↗
• MalfunctionDec 28, 2022Output Problem; Output Problem

  DURING THE PROCEDURE, THE GENERATOR SHOWED AN UNSAFE CONDITIONS ERROR MESSAGE. AS A RESULT, THE PROCEDURE WAS ABANDONED COULD NOT BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061183 ↗
• MalfunctionDec 9, 2022No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SCREEN SWITCHED OFF DURING THE PROCEDURE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, THE PROCEDURE WAS ABANDONED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954770 ↗
• MalfunctionOct 17, 2022Insufficient Heating; Insufficient Heating

  DURING THE PROCEDURE, THE GENERATOR WAS NOT REACHING TEMPERATURE OR STARTING TREATMENT. THE PROCEDURE WAS CANCELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613299 ↗
• MalfunctionAug 26, 2022Power Problem; Power Problem

  DURING THE PROCEDURE, THERE WAS AN ENERGY DROP WHEN THE DEVICE WAS POWERED ON. AFTERWARDS,THE GENERATOR STOPPED WORKING. THE PROCEDURE WAS CANCELLED AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307124 ↗
• MalfunctionAug 17, 2022Output Problem; Output Problem

  DURING PREPARATION FOR THE PROCEDURE, THE GENERATOR SHOWED AN ERROR MESSAGE "TURN RF POT OFF BEFORE CONTINUING." TROUBLESHOOTING INSTRUCTIONS WERE FOLLOWED BUT THE ISSUE PERSISTED AND THE CASE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241142 ↗
• MalfunctionJul 18, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THE PROCEDURE WAS ABANDONED BECAUSE THE MACHINE DISPLAYED A HIGH TEMPERATURE ERROR MESSAGE AND ENTERED SAFE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041445 ↗
• InjuryMay 27, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THE PROCEDURE WAS ABANDONED BECAUSE THE GENERATOR LOST POWER DURING THE PROCEDURE AND COULD NOT BE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526734 ↗
• MalfunctionFeb 23, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE PULSED TREATMENT, THE SCREEN OF THE GENERATOR HAD A DISPLAY ISSUE AND THE PROCEDURE WAS CANCELLED. THERE WAS NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587106 ↗
• MalfunctionJan 28, 2022Mechanical Problem; Mechanical Problem

  DURING THE PROCEDURE, CHANNEL ONE ON THE GENERATOR WAS NOT ABLE TO CONDUCT THE SENSORY AND MOTOR RESPONSE TEST AND THE PROCEDURE WAS CANCELLED AS A RESULT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE GENERATOR WAS LATER REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384949 ↗
• MalfunctionJan 12, 2022Failure to Power Up; Failure to Power Up

  DURING THE PROCEDURE, WITH THE PATIENT ON THE TABLE, THE UNIT WAS NOT RESPONDING AND THE CASE WAS CANCELLED. THE LEFT SIDE OF THE UNIT DOES NOT RESPOND AND THE RIGHT SIDE LIMITED RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236688 ↗
• MalfunctionOct 26, 2021Failure to Deliver Energy; Failure to Deliver Energy

  DURING THE PRF PROCEDURE, WHILE LESIONING, THERE WERE INTERRUPTIONS IN OUTPUT DELIVERY. WHILE ATTEMPTING TO LESION, THERE WAS A DISRUPTION IN THE DELIVERY OF CURRENT. THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS ISSUE. THE SYSTEM WILL BE SENT BACK FOR REPAIR TO RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698952 ↗
• MalfunctionOct 8, 2021Failure to Deliver Energy; Failure to Deliver Energy

  DURING A RIGHT L3, L4 MEDIAL BRANCH AND L5 DORSAL RAMUS RADIOFREQUENCY NEUROTOMY PROCEDURE, THE GENERATOR WOULD NOT COMPLETE THE LESION AND THE CASE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT. THE PROCEDURE HAS BEEN RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599651 ↗
• InjurySep 8, 2021Unintended Electrical Shock; Unintended Electrical Shock

  DURING THE PROCEDURE, SENSORY TESTING WAS TESTED WITHOUT A GROUNDING PAD ON. THERE WAS NO CURRENT OUTPUT NOTICED AND IT WAS NOTICED THAT THE GROUNDING PAD WAS NOT PLUGGED IN. WHEN IT WAS PLUGGED IN, WITH THE GENERATOR SET TO SENSORY OUTPUT, THE PATIENT EXPERIENCED A SHOCK. NO TREATMENT WAS PERFORMED AS THE PATIENT REMAINED STABLE THROUGHOUT. PER THE PHYSICIAN, THIS EVENT WAS DUE TO USER ERROR. THERE WAS NO WARNING DISPLAYED ON THE GENERATOR AT ANY TIME. THE PROCEDURE WAS COMPLETED WITH NO FURTHER CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442041 ↗
• MalfunctionAug 10, 2021Insufficient Heating; Insufficient Heating

  DURING THE PROCEDURE, THE GENERATOR WOULD NOT REACH A TEMPERATURE ABOVE 34-38 DEGREES CELSIUS AND THE PROCEDURE HAD TO BE CANCELLED. THE GROUNDING PAD AND IMPEDANCE LEVELS WERE CHECKED AND SINGLE ELECTRODE MODE WAS ATTEMPTED, BUT THE ISSUE REMAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303081 ↗
• MalfunctionJul 19, 2021Insufficient Heating; Insufficient Heating

  DURING THE PROCEDURE, THE GENERATOR WOULD NOT REACH THE APPROPRIATE TEMPERATURE AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188452 ↗
• MalfunctionJul 7, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PRIOR TO THE PROCEDURE, AFTER THE PATIENT WAS PREPPED, THE SCREEN OF THE SYSTEM WOULD GO BLACK WITH GREEN LINES AFTER BEING TURNED ON. THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE SYSTEM WILL BE SENT FOR REPAIR TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131249 ↗
• MalfunctionJun 22, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN RF PROCEDURE, THE NEUROTHERM 1100 COULD NOT RECOGNIZE THE ADAPTOR CABLE. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12045836 ↗
• MalfunctionJun 10, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, THE GENERATOR WAS NOT ABLE TO RECOGNIZE THE ADAPTER CABLE AND THE GROUNDING PAD AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980388 ↗