NIM-Response® 8253002 (UDI 00613994529053)Recalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 00613994529053), received between Feb 23, 2017 and Sep 24, 2026 — classified as 8 injuries, 163 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (80 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 171 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880080 ↗
• MalfunctionJun 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE OP THERE WAS NO STIMULATION RESPONSE FOR MAINFRAME. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404623 ↗
• MalfunctionMay 27, 2026False Negative Result

  IT WAS REPORTED THAT PRE-OP, THE MAINFRAME WAS UNABLE TO PICK UP SIGNAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296678 ↗
• MalfunctionMar 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE USE, THE MAINFRAME HAD NO STIMULATION RESPONSE WHEN PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684349 ↗
• MalfunctionMar 24, 2026False Negative Result

  IT WAS REPORTED THAT BEFORE OPERATION SOMETIMES THE SIGNAL IS POOR, THE DEVICE CANNOT FUNCTION PROPERLY AND A BACK-UP MACHINE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672135 ↗
• MalfunctionMar 16, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT MAINFRAME HAD DISTURBED SIGNAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602478 ↗
• MalfunctionFeb 9, 2026False Negative Result

  IT WAS REPORTED THAT DURING SET-UP, THE UNIT DOES NOT READ DATA FROM THE PATIENT'S ELECTRODES ON THE NERVE SENSOR MONITOR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289445 ↗
• MalfunctionDec 25, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT INTRA-OP, DURING THE MEASUREMENT, THEY KEPT HEARING A BEEPING SOUND. WE KNOW THE BIS MEASUREMENT CAN INTERFERE, BUT IT WASN'T BEING USED AT THE TIME. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894523 ↗
• MalfunctionDec 25, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE HAD A POTENTIAL CAUSE OF THE SPURIOUS SIGNALS. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894467 ↗
• MalfunctionNov 25, 2025False Negative Result; False Negative Result

  IT WAS REPORTED AFTER STIMULATION WITH THE PROBE, THERE WAS NO RESPONSE (NEGATIVE OR POSITIVE). THE ERROR PERSISTS EVEN AFTER CHANGING THE PROBE. IT COULD BE THE COMMAND FUSES, BUT WE ARE NOT SURE.THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23641035 ↗
• MalfunctionNov 25, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT HALFWAY THROUGH THE MASTOID PROCEDURE, AFTER STIMULATION WITH THE PROBE, THERE WAS NO RESPONSE (NEGATIVE OR POS ITIVE). THIS HAD HAPPENED BEFORE. THE ERROR PERSISTS EVEN AFTER CHANGING THE PROBE. IT COULD BE THE COMMAND FUSES, BUT WE ARE NOT SURE. THE PROCEDURE WAS COMPLETED WITHOUT USING THE MONITORIZATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641011 ↗
• MalfunctionOct 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT INTRA-OP, THERE WAS PROBLEM WITH THE CONNECTIVITY OF DATA TRANSFER FROM THE PROBE TO THE INTERFACE AND MONITOR. THERE WERE READING ISSUE AND SIGNAL NOISE FROM THE SYSTEM. PROLONGED TREATMENT. THE SUBSEQUENT ELECTRODES WERE REPLACED AND THAT ALSO DID NOT WORK PROPERLY. SOME STIMULATION PORTS ARE NON-FUNCTIONAL, RESULTING IN THE INABILITY TO DELIVER ELECTRICAL STIMULATION THROUGH SPECIFIC CHANNELS. PROCEDURE WAS COMPLETED USING ANATOMICAL LANDMARKS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320548 ↗
• MalfunctionOct 15, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT PRIOR TO USE, MAINFRAME HAD NOISY ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276341 ↗
• MalfunctionAug 7, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING AN EXCISION OF SUBMANDIBULAR TUMOR, THE MAINFRAME WAS MALFUNCTIONING, NO STIMULATION RESPONSE. THE SYSTEM ONLY DETECTS INCREASES AND DECREASES IN POWER. THE PROBE WAS CHANGED WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT NOT WORKING, AS THERE WERE NO ALTERNATIVES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735997 ↗
• MalfunctionJul 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, NO CURRENT WAS PASSED. THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584469 ↗
• MalfunctionJul 7, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED WITH REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414567 ↗
• MalfunctionJul 7, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE NIM MAINFRAME BEEPS CONTINUOUSLY DURING USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411800 ↗
• MalfunctionJun 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING COMBINED APPROACH TYMPANOPLASTY OPERATION, STIMULATOR PROBE WHICH WHEN ATTACHED TO A PATIENT IT IS ONLY GIVING A READING INTERMITTENTLY. INTERMITTENT SIGNAL LOSS BUT DID WORK WHEN REQUIRED. THE PROCEDURE COMPLETED WITH REPORTED PRODUCT. THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217093 ↗
• MalfunctionMay 9, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, THE DEVICE CONSTANTLY SENDS FALSE SIGNALS, MAKING IT IMPOSSIBLE TO READ SIGNALS FROM THE LARYNGEAL NERVE. THE DEVICE GIVES AN PERMANENT VOICE SIGNAL AND GRAPHIC ON THE SCREEN SIMILAR TO WHEN THERE ARE ARTIFACTS RECOGNIZED. THEY TRIED STIMULATING, BUT FROM THE RESPONSE OF THE DEVICE, IT WAS IMPOSSIBLE TO READ THE SIGNALS. REPOSITIONING OF THE TUBE WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITHOUT NERVE MONITORING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991273 ↗
• MalfunctionApr 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT NIM WAS NOT WORKING CORRECTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863119 ↗
• MalfunctionApr 3, 2025False Negative Result; False Negative Result

  ADDITIONAL INFORMATION RECEIVED THAT THE EVER OCCURRED DURING PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762698 ↗
• MalfunctionMar 14, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT INTRA-OP, AFTER CONNECTING THE ELECTRODES TO THE REMOTE CONTROL, ALL GREEN ACTIVE ELECTRODES ILLUMINATED ON THE MONITOR. HOWEVER, NO RESPONSE WHEN CHECKING THE NERVES, DESPITE TOUCHING THE NERVES UNDER EYE CONTROL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604487 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING DEMO INSTALLATION, WHEN CONNECTING OUR DEVICE, IT APPEARS THAT THE PROBE IS NOT RECOGNIZED AND THAT THE DEVICE DOES NOT FUNCTION PROPERLY. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556849 ↗
• MalfunctionMar 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE MAINFRAME WASN'T RECOGNIZING THE ELECTRODES WHEN ATTACHED. THERE APPEARS TO HAVE BEEN SOME PIECE OF EQUIPMENT IN A THEATRE CLOSE BY OR SOME HOSPITAL PLANT EQUIPMENT ABOVE THE THEATRE WHICH WAS CAUSING ELECTRICAL INTERFERENCE WITH THE NIM. THIS ISSUE ONLY OCCURRED IN THIS THEATRE. THE BIOMEDICAL ENGINEERING DEPARTMENT HAVE TESTED ALL EQUIPMENT IN THAT THEATRE AND UNFORTUNATELY THE CAUSE OF THE ELECTRICAL INTERFERENCE WAS NOT LOCATED. THIS WAS JUST BEFORE SURGERY AS THE TEAM WERE PREPARING THE PATIENT THEY WERE UNABLE TO GET CONFIRMATION FROM THE NIM THAT THE ELECTRODES WERE CORRECTLY PLACED. THERE WAS NO GREEN TICK INDICATORS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536071 ↗
• MalfunctionMar 5, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE DEVICE AUDIBLY INDICATES THAT IT IS NEAR A NERVE, BUT THIS IS NOT THE CASE AT ALL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526396 ↗

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-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
• 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