NIM® 8253402Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169547087), received between May 16, 2025 and Sep 11, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (19 reports).

3 other recalls cover devices cleared under the same FDA submission (K083124); they may or may not involve this specific model.

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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726075 ↗
• MalfunctionAug 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that intra-op, the NIM 3.0 device was not working - any signal from stimulation; not even negative; they tried to use a lot of different probes. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50266288 ↗
• MalfunctionJun 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, MAINFRAME WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605738 ↗
• MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE MAINFRAME WAS NOT WORKING PROPERLY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25274727 ↗
• MalfunctionMay 25, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE NIM HAD NO STIM RESPONSE. SOMETIMES THE CHANNEL FUNCTION DOESN'T WORK PROPERLY AND THERE IS NO RESPONSE TO STIMULATION. ONE CHANNEL'S STIMULATION FEEDBACK IS 0, WHILE THE OTHERS ARE NORMAL. CHANNEL 1 HAS NO WAVEFORM AND NO STIMULATION FEEDBACK SOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273445 ↗
• MalfunctionMay 19, 2026False Negative Result

  IT WAS REPORTED THAT PRE-OP, THERE WAS NO STIMULATION RESPONSE. PROCEDURE WAS COMPLETED USING OTHER EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212443 ↗
• MalfunctionMay 7, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-OP, THE MAINFRAME WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108387 ↗
• MalfunctionApr 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE MAINFRAME WAS NOT WORKING PROPERLY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030402 ↗
• MalfunctionApr 13, 2026Signal Artifact/Noise; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING INTRA-OP, THE NIM 3.0 HAD INTERFERENCE LEVELS EXCESSIVELY HIGH, TO THE POINT THAT STIMULUS DETECTION WAS NOT POSSIBLE. THE SIGNAL WAS COMPARABLE TO A MONOPOLAR ELECTRODE WITHOUT A SILENCER, PRESENTING CONSTANT HIGH-AMPLITUDE OSCILLATIONS AND A CONTINUOUSLY REPETITIVE PATTERN, ALONG WITH A PERSISTENT STIMULATION ALERT TONE. THIS CONDITION REMAINED CONSTANT THROUGHOUT THE ENTIRE PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24854680 ↗
• MalfunctionApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING USE, NIM CONSOLE HAD INTERMITTENT SYSTEM FAILURES STARTUP ERRORS, EXCESSIVE INTERFERENCE, AND DISABLED EMG MONITORING DESPITE CONSISTENTLY PASSING ALL TESTS AND CHECKS. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO DETECT ANY TYPE OF SIGNAL, NEITHER NEURAL ACTIVITY NOR INTERFERENCE, INCLUDING NO SIGNAL FROM THE UNSILENCED ELECTRODE. A FULL SYSTEM CHECK WAS PERFORMED MULTIPLE TIMES, INCLUDING REPEATED TEST FUNCTION VERIFICATION, CONSISTENTLY CONFIRMING PROPER SYSTEM PERFORMANCE. CONNECTIONS, CONFIGURATIONS, AND OTHER PARAMETERS WERE REVIEWED WITHOUT SUCCESS. DURING THE FINAL 15 MINUTES OF THE PROCEDURE, THE PHYSICIAN DECIDED TO USE A PERSONAL PORTABLE DEVICE. UPON STIMULATION WITH THAT DEVICE, A SIGNAL WAS DETECTED ON OUR SYSTEM (WITHOUT ANY CHANGES MADE SINCE THE LAST TEST, DURING WHICH NO SIGNALS HAD BEEN DETECTED). AT THAT POINT, I SUGGESTED THAT THE PHYSICIAN ATTEMPT NERVE STIMULATION AGAIN, RESULTING IN A POSITIVE RESPONSE, ALTHOUGH WITH LOW AMPLITUDE (100 V). THIS EVENT WAS RECORDED AND SUBSEQUENTLY SAVED TO A USB DRIVE. THE SYSTEM HAD PASSED THE TEST FUNCTION SUCCESSFULLY. FOLLOWING THE ISSUE, STANDARD TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842395 ↗
• MalfunctionMar 30, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT AFTER THE OPERATION, THE NIM SYSTEM CRASHED EVERY TIME. THE PROTOCOL WAS SAVED TO A USB STICK. NO LOG COULD BE SAVED. SINCE THERE WAS NO INTERNAL MEMORY ON THE DEVICE, THE DATA COULD NO LONGER BE SAVED EITHER.THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725700 ↗
• MalfunctionMar 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE DEVICE WAS UNABLE TO START/OPERATE NORMALLY, WHICH LED TO INTERRUPTION IN INTENDED USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542619 ↗
• MalfunctionFeb 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING SETUP THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288689 ↗
• MalfunctionJan 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE MAINFRAME HAD NO STIMULATION RESPONSE. THE STIMULUS RETURN DISPLAYED AS "0," AND ¿STIMULUS DELIVERY¿ TONE WAS NOT HEARD WHEN ATTEMPTING TO STIMULATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220802 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING POST-OP, THE NIM MAINFRAME WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186162 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE MAINFRAME WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186059 ↗
• MalfunctionJan 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941246 ↗
• MalfunctionDec 30, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT PRE-OP, THE DEVICE HAD A LOT OF INTERFERENCE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920290 ↗
• MalfunctionDec 22, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRIOR TO USE, NIM EQUIPMENT IS UNDER BREAKDOWN AND IS NOT DETECTING SIGNALS. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862286 ↗
• MalfunctionDec 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  EVENT OCCURRED DURING INTRA-OP THAT THE DEVICE IS NOT ACCURATE AND INDICATED IT WAS NERVE WITH OTHER TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861992 ↗
• MalfunctionDec 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO PROCEDURE THE NIM 3.0 MAINFRAME WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690866 ↗
• MalfunctionAug 28, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRE OP, DEVICE HAD NO SOUND. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911249 ↗
• MalfunctionAug 19, 2025Break; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Break; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING DEMO OR INSTALLATION, WHEN USER STIMULATE, NIM 3.0 EQUIPMENT DON¿T RECOGNIZE THE SIGNAL. ALSO, DON¿T MUTE THE ELECTRONIC INTERFERENCES. THE MUTE CONNECTOR IS BROKEN OR LOOSE. WHEN THEY USE PATIENT SIMULATOR AND HAVE THE SAME RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838088 ↗
• MalfunctionAug 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE MAINFRAME WAS SLOW TO OPERATE DURING IGNITION AND ALSO CHECKED THE PATIENT INTERFACE WHERE THE ELECTRODES ARE INSERTED AS PROBLEMS HAVE OCCURRED IN THE RETURN OF THE GROUNDING. DESPITE THE FORKLIFT REMOTE CONTROL, THE MACHINE IS ALWAYS SLOW AND HAS TURNED OFF DURING THE INTERVENTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734787 ↗
• MalfunctionJul 30, 2025Computer Software Problem; Failure to Power Up; Computer Software Problem; Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO PROCEDURE THE NIM 3.0 MAINFRAME DID NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666593 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083124. One submission often covers many models, so check the product and lot details in each record.

• Z-2344-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patie
• Z-2343-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patie
• Z-2342-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient