NIM-Response® 8253002 (UDI 00643169230392)Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00643169230392), received between Dec 2, 2016 and Aug 28, 2026 — classified as 4 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (33 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. 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 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493560 ↗
• MalfunctionJun 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE DEVICE, THE CUSTOMER OBSERVED THAT ONE VOCAL CORD WAS ONLY INTERMITTENTLY DETECTED, RESULTING IN THE INDICATOR LIGHT ALTERNATING BETWEEN GREEN AND RED. REPOSITIONING THE ENDOTRACHEAL TUBE DID NOT RESOLVE THE ISSUE. TO ISOLATE THE SOURCE OF THE MALFUNCTION, PERFORMED A TEST WITH ANOTHER PACEMAKER USING THE SAME ACCESSORIES: NO DEFECTS WERE FOUND, LEADING US TO CONCLUDE THAT THE FAILURE IS INDEED ATTRIBUTABLE TO THE MAINFRAME, USED ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499037 ↗
• MalfunctionMar 17, 2026False Negative Result

  IT WAS REPORTED THAT PRE-OP, THE DEVICE DOES NOT SHOW ANY REACTIONS ON THE SCREEN WHILE THE SOUND WORKED CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614290 ↗
• MalfunctionMar 2, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE EVENT OCCURRED DURING SET UP FOR A THYROIDECTOMY WHEREIN THERE WERE NO CHANGES OBSERVED IN THE SET UP MENU AFTER PLUGGING THE PLUGS INTO INTERFACE SOCKETS. THE PROCEDURE COULD NOT BE COMPLETED WITH THE REPORTED DEVICE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT OCCURRED DURING SET UP FOR A THYROIDECTOMY WHEREIN THERE WERE NO CHANGES OBSERVED IN THE SET UP MENU AFTER PLUGGING THE PLUGS INTO INTERFACE SOCKETS. THE PROCEDURE COULD NOT BE COMPLETED WITH THE REPORTED DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24479798 ↗
• MalfunctionFeb 23, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT NIM 3.0 WAS NOISY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411134 ↗
• MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SURGERY, THE NIM MAINFRAME WAS STOPPED WORKING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343655 ↗
• MalfunctionDec 18, 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 SYSTEM GIVES ALARMS, PROBLEMS ENCOUNTERED AFTER TURNING ON THE DEVICE DURING SELF-TEST VERIFICATION AND INTERFERENCE ON ONE CHANNEL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836337 ↗
• MalfunctionNov 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DEVICE WAS DEFECTIVE. THERE IS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED, THE PROBLEM HAVE BEEN FIXED EASILY AND ALONE. IT WAS DURING THE TEST WITH SIMULATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677054 ↗
• MalfunctionNov 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE NIM 3.0 MAINFRAME WAS NOT WORKING PROPERLY, SOMETIMES THE CURRENT FEEDBACK IS INACCURATE. ISSUE WAS NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640781 ↗
• MalfunctionNov 21, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE MAINFRAME UNIT HAD AN INTERFERENCE ISSUE DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615269 ↗
• MalfunctionNov 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE THE OPERATION, THE MAINFRAME WAS NOT WORKING. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590804 ↗
• MalfunctionOct 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE THE OPERATION, THE NIM SYSTEM DID NOT HAVE A STIMULATION RESPONSE. THE PROBE WAS WORKING FINE WITHOUT ANY ISSUES WHEN TESTED WITH ANOTHER PATIENT INTERFACE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360406 ↗
• MalfunctionAug 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, WHEN  PATIENT LEADS CONNECTED TO THE MONITOR DOES NOT WORK HOWEVER, WHEN THE SAME LEADS ARE CONNECTED TO A DIFFERENT MONITOR, THEY FUNCTION CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. PROCEDURE WAS COMPLETED WITH THE BACK UP DEVICE. WHEN THE TECHNICIAN PERFORMED TROUBLESHOOTING WITH THE OTHER LEAD , THE ISSUE WAS NOT DUPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872264 ↗
• MalfunctionAug 1, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THE PROCEDURE, MULTIPLE SIGNALS (WAVES) WERE DETECTED, INTERFERENCE IN THE SIGNAL EVEN WHEN THERE WAS NO CONTACT WITH THE PATIENT. HOWEVER, NERVE STIMULATION WAS STILL ACHIEVABLE. STIMULUS WAS SET TO 0.8 MA AND THRESHOLD: 100 V . THE FUSES ON THE PI BOX WERE REPLACED. THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCT. STIMULUS DELIVERY TONE WAS HEARD AND WAVE FORM WAS VISIBLE WHEN ATTEMPTING TO STIMULATE THE NERVE. WHEN TESTING THE SYSTEM WITH THE NIM 3.0 UNIVERSAL SIMULATOR, THE ISSUE OF MULTIPLE SIGNALS (WAVES) WAS NOT REPRODUCED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684145 ↗
• MalfunctionAug 1, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THE PROCEDURE, MULTIPLE SIGNALS (WAVES) WERE DETECTED, INTERFERENCE IN THE SIGNAL EVEN WHEN THERE WAS NO CONTACT WITH THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED BY ALSO USING ANOTHER NIM 3.0 UNIT AVAILABLE AT THE FACILITY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684128 ↗
• MalfunctionJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PREOPERATIVELY, THE NIM3.0 WAS NOT WORKING PROPERLY, NO CURRENT RETURN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573600 ↗
• MalfunctionJul 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT MAINFRAME WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435244 ↗
• MalfunctionJul 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE HAD UNKNOWN FAILURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391973 ↗
• MalfunctionJun 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION THE DEVICE HAD NO STIMULATION RESPONSE. THE STIM RETURN WAS NOT SHOWING 0. THERE WAS STIMULUS TONE HEARD AND WAVEFORM DISPLAYED WHEN STIMULATING THE NERVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355281 ↗
• MalfunctionJun 13, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT NIM 3.0 HAD NO CONNECTION AND NO READINGS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204706 ↗
• MalfunctionMay 15, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING THYROID PROCEDURE THE DEVICE SWITCHES OFF DURING USE. THE PROCEDURE WAS COMPLETED USING REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032643 ↗
• MalfunctionApr 28, 2025False Negative Result; False Negative Result

  IT WAS REPORTED DURING INTRA-OP FOR THYROIDECTOMY PROCEDURE THAT THE DEVICE HAD NO SIGNAL FOR THE NIM WHEN THEY WAS CLOSE TO THE NERVE. PROCEDURE WAS COMPLETED WITH REPORTED PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917776 ↗
• MalfunctionApr 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT POST-OP, THERE WAS CLUTTER AND THE SIGNAL WAS ABNORMAL. 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 21906189 ↗
• MalfunctionMar 26, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRE-OP, THE DEVICE HAD NO STIMULATION RESPONSE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694661 ↗
• MalfunctionMar 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING INTRA-OP, THE NIM HAD FUNCTION FAILURE, VALUES CHANGE ARBITRARILY. THE STIMULATION AUTOMATICALLY JUMPED TO 3 MA WITHOUT ANY ACTIVE CHANGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635618 ↗

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-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
• 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