NIM-Response® 8253001 (UDI 00643169782549)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00643169782549), received between Jun 19, 2018 and Sep 28, 2026 — classified as 3 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (18 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Inappropriate Audible Prompt/Feedback

  It was reported that the mainframe is giving reactive noise. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911022 ↗
• MalfunctionJan 2, 2026False Negative Result; False Positive Result

  IT WAS REPORTED THAT DURING A CASE, NIM3.0 MACHINE STIMULATING NERVE WHEN NOT ACTIVATED AND NOT STIMULATING THE NERVE WHEN ACTIVATED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941241 ↗
• MalfunctionDec 10, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE SYSTEM WAS GIVING A "POOR RESPONSE" WHEN TESTING THE SYSTEM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766662 ↗
• MalfunctionDec 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT NIM MAINFRAME, STANDARD MONOPOLAR PROBE WAS NOT RESPONDING, EVEN AFTER TRYING MULTIPLE PROBES, DOUBLE-CHECKING THE SETTINGS, AND ENSURING PROPER GROUNDING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690806 ↗
• MalfunctionNov 19, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING INTRAOPERATIVE THE NIM MAINFRAME WAS PICKING UP EXCESSIVE SIGNAL, EVEN WHILE THE SURGEON WAS NOT ACTIVELY STIMMING THE PATIENT. DURING TROUBLESHOOTING, THE SITE DID NOT HAVE A MUTING PROBE PLUGGED IN. ONCE PLUGGED IN, THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590548 ↗
• MalfunctionSep 18, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT WHILE IN SURGERY, THE SYSTEM WENT UNRESPONSIVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084979 ↗
• MalfunctionSep 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE IN SURGERY, THE SYSTEM "WOULD NOT CONNECT TO THE PATIENT AND WAS GIVING NO SIGNAL ON THE SCREEN. THERE WAS NO PATIENT IMPACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050118 ↗
• MalfunctionAug 25, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TESTING, THE NIM3.0 WAS NOT WORKING CORRECTLY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891923 ↗
• MalfunctionAug 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT MAINFRAME HAD SOME MALFUNCTION. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22881709 ↗
• MalfunctionJul 25, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE OBSOLETE SYSTEM HAS ALWAYS PRODUCED SIGNIFICANT ARTIFACT AND CONTINUES TO DO SO. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22605799 ↗
• MalfunctionJun 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP OF PARATHROIDECTOMY PROCEDURE, MAINFRAME WAS NOT WORKING. REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328458 ↗
• MalfunctionJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFO RECEIVED STATING THAT A SEPARATE NIM 3.0 WAS BROUGHT IN TO COMPLETE THE CASE. BIOMED TESTING WAS COMPLETED AFTER THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305348 ↗
• MalfunctionJun 17, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT SYSTEM IS NOT GIVING ANY OUTPUT AND "ACTS LIKE THERE IS A SHORTAGE". NO SELF TEST WAS PERFORMED AS THEY WERE CONNECTED TO A PATIENT AT THE TIME. REPORTER WAS NOT IN FRONT OF THE SYSTEM TO PERFORM ANY TROUBLESHOOTING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216821 ↗
• MalfunctionJun 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP, THE NIM MAINFRAME WAS WORKING INTERMITTENTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192397 ↗
• MalfunctionMay 16, 2025Computer Software Problem; Application Program Freezes or Fails to Launch; Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE NIM MAINFRAME WAS CRASHING (SHUTTING DOWN) AND RESTARTING MULTIPLE TIMES DURING A PROCEDURE. STAFF NOTED THAT THE SYSTEM WOULD FREEZE, OFTEN GETTING STUCK ON THE CLOCK LOADING SCREEN, AND THE MAIN TERMINAL WOULD EITHER FREEZE OR CRASH MID-PROCEDURE. EACH TIME, THE STAFF WERE ABLE TO TEMPORARILY RESTORE FUNCTIONALITY BY POWER CYCLING THE UNIT, BUT THE ISSUE WOULD RECUR INTERMITTENTLY. TROUBLESHOOTING WAS CONDUCTED DURING THESE EVENTS, AND ALTHOUGH THE PROBLEM PERSISTED THROUGHOUT THE CASE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE AFFECTED DEVICE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035804 ↗
• MalfunctionMar 24, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE DEVICE HAD ONE OF THEM MESSED UP AND THEY NEEDED TO REBOOT IT. THE SYSTEM "FROZE" THEY HAD TO GET A KEYBOARD TO DO CNTRL +ALT DEL TO GET THE SYSTEM TO WORK. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675503 ↗
• MalfunctionMar 24, 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 NIM MAINFRAME HAD ERROR MESSAGE HARDWARE ISSUE, WHEN PLUGGED THE SIMULATOR IN AND IT WAS GETTING A LOT OF FEEDBACK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675371 ↗
• MalfunctionMar 23, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OPERATIVE, MID SURGERY, THE SYSTEM STOPPED SIGNALING ANY STIMULATION. AT THAT TIME, THE SURGEON HAD ALREADY LOCATED THE NERVE, BUT THE SYSTEM STOPPED MAKING ANY NOISE, INCLUDING BELOW THRESHOLD SIGNALS. THE SITE REBOOTED THE SYSTEM AND SWAPPED TO A DIFFERENT STIMULATOR. THE ISSUE STILL PERSISTED.. SITE NOTED THAT THE LAST KNOWN STIM ON THE SYSTEM WAS 139UV, WHILE THE THRESHOLD WAS 100UV. PROCEDURE EXTENDED FOR LESS THAN A HOUR. THERE WAS NO PATIENT IMPACT. THE FUSE WAS REPLACED AND THE SYSTEM IS WORKING AS INTENDED NOW.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21673149 ↗
• MalfunctionMar 13, 2025False Negative Result; False Negative Result

  IT WAS REPORTED DURING TESTING, THE SYSTEM WAS NOT GIVING ANY RESPONSE WITH THE SIMULATOR. TROUBLESHOOTING PERFORMED. THE CONSOLE WAS READING/PICKING UP RESPONSES BY LIGHTLY TAPPING ON THE ELECTRODES PLUGGED INTO THE INTERFACE BOX. THEN TRIED TO STIMULATE A CORRESPONDING ELECTRODE PAIR AND THERE WAS NO RESPONSE FROM THE SYSTEM. MOVED THE PROBE TO STIM 2 AND ADJUST THE STIM/THRESHOLD AND GOT A RESPONSE. PLUGGED BACK INTO STIM 1 AND ADJUSTED THE STIM/THRESHOLD VALUES AND THERE WAS STILL NO RESPONSE ON THE SYSTEM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593494 ↗
• MalfunctionMar 7, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT STAFF KEEPS COMPLAINING THAT ONE OF THE PORTS IS UNRESPONSIVE. EVERY TIME THE USER CHECKS THE UNIT, ALL THE PORTS SEEM FINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21544683 ↗
• MalfunctionFeb 24, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE DEVICE GAVE NO OUTPUT. TROUBLESHOOTING WAS DONE BY CHECKING THE FUSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455261 ↗
• MalfunctionNov 18, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING PARATHYROID PROCEDURE, THE FACIAL NERVE MONITORING DID NOT "ALARM" LIKE IT USUALLY DOES - INSTEAD IT HAD ONE TONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703345 ↗
• MalfunctionOct 9, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT INTRA-OP, THE SYSTEM IS READING FALSE POSITIVES, PICKING UP SIGNAL WHEN IT'S ON TISSUE AS WELL AS NERVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405172 ↗
• MalfunctionSep 16, 2024Computer Software Problem; Inappropriate Audible Prompt/Feedback; Computer Software Problem; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE NERVE LOCATOR WAS ALARMING AND MONITOR IS FUZZY, NOT VIEWABLE IN THE NIM MAINFRAME. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20222237 ↗
• MalfunctionSep 10, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT MAINFRAME WILL NOT BOOT UP COMPLETELY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184969 ↗

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-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
• 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