NT2000iX™ RFG-NT-2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 310 adverse event reports that list this exact device (DI 05415067022417), received between Jun 15, 2018 and Aug 27, 2026 — classified as 164 injuries, 146 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (57 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 28, 2023Open, Classified

   Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.

   Z-0209-2024 · Root cause: Process change control · FDA record ↗

2. Apr 22, 2021Terminated

   Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.

   Z-1549-2021 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 310 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported patient was burned during a RF procedure. As a result, the procedure was abandoned.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 50484993 ↗
• InjuryMar 23, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RFA PROCEDURE ON (B)(6) 2025, THE HEALTHCARE PROFESSIONAL RECEIVED AN ERROR MESSAGE INSTEAD AN IMPEDANCE VALUE WHEN ATTEMPTING PERFORM A BURN ON A PATIENT. AS SUCH, THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21673203 ↗
• InjuryMay 13, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED A PROCEDURE WAS ABANDONED DUE TO THE BIPOLAR SETTING NOT FUNCTIONING. ADDITIONAL INFORMATION INDICATES THERE WAS NO MALFUNCTION WITH THE GENERATOR AND THE ISSUE WAS LATER ABLE TO BE RESOLVED VIA EDUCATION OF THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298486 ↗
• MalfunctionJan 7, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THIS DEVICE WAS IDENTIFIED AS BEING SERVICED USING A TOOL THAT WAS SUBSEQUENTLY FOUND TO BE OUT OF TOLERANCE AND THEREFORE MAY NOT HAVE PROVIDED ACCURATE RESULTS FOR POTENTIAL CAPACITANCE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461540 ↗
• MalfunctionDec 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GENERATOR WAS UNDER THE RFA RECALL Z-0209-2024. NO APPARENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418278 ↗
• MalfunctionSep 4, 2023Insufficient Heating; Mechanical Problem; Insufficient Heating; Mechanical Problem

  IT WAS REPORTED THAT THE GENERATOR STOPPED WORKING DURING A PROCEDURE. AS A RESULT, THE PROCEDURE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680458 ↗
• InjurySep 4, 2023Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT ON (B)(6) 2023, AFTER THE PATIENT HAD SEDATION, WAS PREPPED, AND HAD CANNULAS IN PLACE THE RFA GENERATOR WAS UNABLE TO GET A BURN. PROCEDURE WAS ABANDONED AND NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675166 ↗
• MalfunctionAug 28, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE GENERATOR MADE A HIGH PITCHED SQUEALING WHINE NOISE WHILE TRYING TO GET TO TEMPERATURE. REPORTEDLY, THE IMPEDANCE VALUES WERE VERY HIGH. IT WAS REPORTED THAT SMOKE WAS SEEN COME FROM THE GENERATOR AND SMELLED A BURNING SMELL. ONE PORT WAS NOT GETTING TO TEMPERATURE AT ALL. THE PROCEDURE WAS COMPLETED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638254 ↗
• MalfunctionJul 5, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN RFA PROCEDURE, THE GENERATOR COULD NOT PRODUCE ENOUGH OUTPUT TO CONTINUE THE PROCEDURE. TROUBLESHOOTING ATTEMPTS WERE UNSUCCESSFUL. AS A RESULT, THE PROCEDURE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263568 ↗
• InjuryApr 17, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023 THE GENERATOR WAS NOT HEATING PROPERLY. THE TEMPERATURE INCREASED UP THAN THE RECORDED TEMPERATURE DURING LESIONING AT SEVERAL VOLTAGE SETTINGS. SUBSEQUENTLY, THE DOCTOR STOPPED USING THE DEVICE AND PROCEDURE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751358 ↗
• InjuryApr 11, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE GENERATOR WAS NOT HEATING PROPERLY. THE TEMPERATURE INCREASED UP THAN THE RECORDED TEMPERATURE DURING LESIONING AT SEVERAL VOLTAGE SETTINGS. SUBSEQUENTLY, THE DOCTOR STOPPED USING THE DEVICE AND PROCEDURE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710842 ↗
• MalfunctionFeb 5, 2023Output Problem; Output Problem

  DURING A SIMPLICITY PROCEDURE, THE GENERATOR SHOWED AN ERROR MESSAGE. TROUBLESHOOTING WAS ATTEMPTED BUT THE ISSUE PERSISTED. 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 16302123 ↗
• MalfunctionJan 9, 2023Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 THE SECOND GATE WAS NOT WORKING. THERE WAS NO SIGNAL AND AN IMPEDANCE WAS OBSERVED. REPORTEDLY, IT WAS NOT POSSIBLE TO TEST SENSORIC AND MOTORIC. HENCE, THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122117 ↗
• MalfunctionDec 29, 2022Smoking; Smoking

  DURING THE PROCEDURE, THE GENERATOR WAS SMOKING. THE PROCEDURE WAS STOPPED AND COULD NOT BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16071569 ↗
• MalfunctionDec 28, 2022No Display/Image; No Display/Image

  DURING THE PROCEDURE, THE GENERATOR MADE A CONTINUOUS BEEP AND THE SCREEN WENT BLACK. THE GENERATOR WAS RESTARTED, HOWEVER, THE ISSUE WAS NOT RESOLVED. AS A RESULT, THE PROCEDURE COULD NOT BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062000 ↗
• MalfunctionNov 20, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE GENERATOR WAS NOT WORKING, AND AN ERROR MESSAGE WAS RECEIVED. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, THE CASE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831892 ↗
• MalfunctionOct 17, 2022Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613301 ↗
• MalfunctionOct 11, 2022Output Problem; Output Problem

  PRIOR TO THE PROCEDURE STARTING, THE GENERATOR SHOWED AN ERROR MESSAGE. AS A RESULT, THE PROCEDURE COULD NOT BE PERFORMED AND WAS CANCELLED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580085 ↗
• MalfunctionSep 27, 2022Unexpected Shutdown; Unexpected Shutdown

  DURING THE PROCEDURE THE GENERATOR WAS CONSTANTLY SWITCHING OFF. THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491918 ↗
• MalfunctionSep 20, 2022Smoking; Smoking

  DURING THE PROCEDURE, THE GENERATOR STARTED BEEPING AND SMOKING. IT WAS TURNED OFF AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460221 ↗
• MalfunctionSep 1, 2022Failure to Deliver Energy; Failure to Deliver Energy

  RELATED MANUFACTURER REPORT NUMBERS: 2184149-2022-00198, 2184149-2022-00199, 2184149-2022-00200, 2184149-2022-00201, 2184149-2022-00202, 2184149-2022-00203. DURING THE PROCEDURE, THERE WAS A MISSING IMPEDANCE ERROR MESSAGE, AND THE GENERATOR STOPPED WORKING AFTER THE SENSORY AND MOTOR TESTING. THE PROCEDURE COULD NOT BE COMPLETED. HOWEVER AFTER THE PROCEDURE, DURING TROUBLESHOOTING, THE ELECTRODE WAS REPLACED AND THE GENERATOR WAS FUNCTIONING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337317 ↗
• MalfunctionAug 16, 2022Output Problem; Output Problem

  WHEN THE PROCEDURE WAS ABOUT TO BEGIN, AN ERROR MESSAGE APPEARED AFTER THE ELECTRODE WAS CONNECTED TO THE GENERATOR. THE INSTRUCTIONS TO TROUBLESHOOT WAS FOLLOWED, HOWEVER, THE ISSUE PERSISTED AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236769 ↗
• MalfunctionAug 3, 2022Insufficient Heating; Insufficient Heating

  DURING AN RF PROCEDURE, THE GENERATOR CHANNELS DID NOT REACH TARGET TEMPERATURE AND THE PROCEDURE COULD NOT BE COMPLETED. A BLOCK WITH ANESTHETIC WAS MADE IN PLACE OF THE RF PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156534 ↗
• InjuryMay 27, 2022Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THE PROCEDURE WAS ABANDONED BECAUSE THE PORTS ON THE GENERATOR WOULD NOT HEAT APPROPRIATELY. THERE WERE NO PATIENT ADVERSE CONSEQUENCES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526819 ↗
• MalfunctionApr 15, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, WITH THE PATIENT ON THE TABLE, THE GENERATOR SCREEN WAS NOT RESPONDING AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117444 ↗