NIM-Response® 8253001 (UDI 00643169230385)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00643169230385), received between May 11, 2017 and Sep 28, 2026 — classified as 7 injuries, 59 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026False Negative Result

  It was reported that during surgery, the mainframe were not getting any feedback when stimulating. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911109 ↗
• MalfunctionJun 15, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT NIM MAINFRAME WAS SOUNDING WITH UNEXPECTED NOISE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498501 ↗
• MalfunctionMay 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING LEFT THYROIG LOBECTOMY PROCEDURE, THE MAINFRAME UNIT INTERMITTENTLY DISPLAYS THE EMT MONITORING DISABLED MESSAGE, 5 SECONDS DELAYS IN DISPLAYING STIM RESPONSES. TROUBLESHOOTING WAS DONE BY COMPLETING TWO POWER CYCLES ALONG WITH RESEATING AND RE-WRAPPING THE MUTE CABLE. SITE DECIDED TO CONTINUE SURGERY WITH SYSTEM AND THERE WAS A SURGICAL EXTENSION OF LESS THAN ONE HOUR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25198072 ↗
• MalfunctionApr 9, 2026False Negative Result

  IT WAS REPORTED THAT INTRA-OP DURING THYROID PROCEDURE, THE NIM MAINFRAME WAS GIVING FALSE NEGATIVE RESPONSES. THE PROCEDURE WAS COM PLETED WITH THE REPORTED PRODUCT AND NO TROUBLESHOOTING WAS PERFORMED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24827502 ↗
• MalfunctionMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE SYSTEM THAT RESULTED INTO A "PATIENT INCIDENT." THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615263 ↗
• InjuryFeb 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, DR. (B)(6) WAS INFORMED BY A NURSE CONFIDENTIALLY THAT A PATIENT NERVE WAS CUT DURING A CASE WITH DR. (B)(6). THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. PATIENT WAS ALIVE WITH INJURY.

  Patient problems: Nerve Damage

  MAUDE report 24245120 ↗
• MalfunctionDec 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROID SURGERY, NO STIM RESPONSE WAS DETECTED BY THE NIM SYSTEM. THE SURGERY WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766964 ↗
• MalfunctionDec 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA OPERATIVELY, NO STIM RESPONSE WAS DETECTED BY THE NIM SYSTEM. THE EVENT WAS COMPLETED WITH SAME NIM DEVICE AND DISPOSABLES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766865 ↗
• MalfunctionNov 5, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE SYSTEM WAS NOT DISPLAYING ANY WAVEFORMS, DESPITE GIVING THE CORRECT AUDIO TONES. SITE ATTEMPTED TO TROUBLESHOOT BUT COULD NOT GET ANY FIELD IN ELECTRODE CHECK TO PASS. STIM 1 GROUND AND ALL CHANNELS HAD A RED X. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483364 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING SURGERY, THE SYSTEM WAS NOT GIVING A RESPONSE WHEN THE SURGEON STIMMED VIA THE PROBE. TROUBLESHOOTING WAS PERFORMED, SITE CONFIRMED THAT ELECTRODE CHECK HAS PASSED SUCCESSFULLY PRIOR TO CALL. TS HAD SITE FIRMLY TAP THE ELECTRODES ON THE PI BOX. SITE STATED THAT DESPITE FIRMLY TAPPING, THERE WAS NO RESPONSE ON THE NIM. TS SUGGESTED TO SITE THAT THE ELECTRODES COULD BE AT FAULT, AND THAT IF THE SURGEON WAS WILLING, THEY COULD BE RESEATED ON THE PATIENT. SITE ENDED THE CALL SHORTLY AFTER THIS SUGGESTION. PATIENT DEMOGRAPHICS AND SURGERY INFO NOT AVAILABLE AT THE TIME OF CALL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082000 ↗
• MalfunctionJun 16, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT SYSTEM IS NOT GIVING ANY OUTPUT AND "ACTS LIKE THERE WAS A SHORTAGE". NO SELF TEST WAS PERFORMED AS IT WAS ALREADY CONNECTED TO A PATIENT AT THE TIME. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210472 ↗
• MalfunctionApr 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PAROTIDECTOMY, COULDN¿T GET THE STIMULATING PROBE TO WORK. WENT TO STIMULATE, IT WOULDN¿T STIMULATE THE NERVE. THE CHANNEL 1 AND 2 STILL APPEARED TO WORK BUT NO STIMULATION WITH PROBE. SWITCHED TO ANOTHER PROBE AND STILL WOULDN¿T WORK. JUST CHECKED ELECTRODES AND COULDN¿T SEE ANYTHING THAT WASN¿T WORKING. JUST HAPPENED IN MIDDLE OF CASE AFTER PROBE HAD BEEN WORKING. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21897072 ↗
• MalfunctionMar 25, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE USER CONNECTED A WRONG PROBE, AND THAT SHORTED OUT THE NIM CONSOLE. IT WON'T TURN ON AT ALL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687372 ↗
• MalfunctionMar 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 THE SURGEON WOULD LIKE CONTINUOUS STIMULATION. SITE REPORTED WHEN ENTERING ADVANCED SETTINGS, STIM 1 WAS ON MONOPOLAR AND THE RATE WAS SET BUT THE SURGEON WOULD LIKE IT TO BE CONTINUOUS. SURGEON DECIDED TO USE ANOTHER SYSTEM AND NOT USE THE NIM 3.0 FOR THE CONTINUATION OF THE CASE. THERE IS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685298 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING ELECTRODE AND PROBE PLACEMENT PROCEDURE, THE STIMULATION WAS NOT SEEN RETURNED TO THE NIM SYSTEM. TROUBLESHOOTING PERFORMED, THE STIMULATION WAS AT 1.0 MA, AND THE THRESHOLD WAS AT 100 V. RESTARTING THE SYSTEM SEVERAL TIMES BUT THE ISSUE WAS NOT RESOLVED. THE TOTAL DELAY OF THE CASE WAS APPROXIMATELY 1 HOUR AND 15 MINUTES. FURTHER TROUBLESHOOTING REVEALED THAT, THE ELECTRODE CHECK WAS GREEN. THE THRESHOLD WAS TURNED DOWN TO 90 V AND 80 V. A 'TWEEDLE' WAS HEARD. REPOSITIONING THE PROBES WAS NOT DESIRED. A MUTING CLAMP WAS BEING USED. THE SETTING WAS CHANGED FROM SINGLE TONE TO CONTINUOUS TONE. THIS SOLVED THE ISSUE." THE PROBABLE CAUSE MIGHT BE PROBE PLACEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557621 ↗
• MalfunctionMar 6, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE SYSTEM LOST WAVE FORM. DURING TROUBLESHOOTING IT WAS FOUND THAT WHEN THEY PERFORMED ELECTRODE CHECKS AND SYSTEM FUNCTIONING AS INTENDED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543508 ↗
• MalfunctionFeb 26, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT LACK OF RESPONSE WHILE STIMULATING DURING A THYROID PROCEDURE. PASSED ELECTRODE CHECK, USING TRIVANTAGE TUBE, WORKED AT BEGINNING OF SURGERY THEN MADE THUMPING NOISE. SWAPPED CONSOLES AND DID NOT RESOLVE. PROCEDURE DELAYED BY LESS THAN 1 HOUR. IN TROUBLESHOOTING , STIM 1 RETURN REMAINED AT 0.00MA. RECOMMENDED SWAPPING TO STIM 2 AND ACTIVATING. SUSPECT BLOW FUSE, THUMPING NOISE INDICATING STIM NOT RETURNING. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466027 ↗
• MalfunctionDec 29, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE NIM SYSTEM WAS NOT PROVIDING ENOUGH STIMULATION SIGNALS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032884 ↗
• MalfunctionDec 5, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT NOT ACCURATE WHEN IT READS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20850754 ↗
• MalfunctionDec 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING THYROID SURGERY THE SURGEON WAS NOT RECEIVING A RESPONSE DURING TAP TEST DURING THYROID CASE. SHE STATES THAT THE SYSTEM PASSED THE ELECTRODE TEST.  THERE WAS RESPONSES ON BOTH CHANNELS WITH THE SIMULATOR. SYSTEM WAS UNRESPONSIVE. THERE WAS LESS THAN ONE HOUR OF SURGERY DELAY AND SURGERY WAS ABORTED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817249 ↗
• MalfunctionNov 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA OP DURING A THYROIDECTOMY CASE, THE SYSTEM WAS DISPLAYING A STIMULUS OUTPUT FROM THE PATIENTS PACEMAKER BUT NOT THE PROBE WHEN STIMULATING THE EMG TUBE. THE STIM VALUE REACHES THE EXPECTED VALUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20721979 ↗
• InjuryOct 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A PARATHYROIDECTOMY THE SURGEON SEVERED THE TRIGEMINAL NERVE OF THE PATIENT. THEY REPORT THAT THE SYSTEM WAS NOT ACCURATELY REPORTING THE STIMULATION OF THE PATIENT IN THE MONITORING SCREEN. THE PROCEDURE WAS DELAYED MORE THAN AN HOUR TO ALLOW FOR SURGICAL REPAIR OF THE RECURRENT LARYNGEAL NERVE.

  Patient problems: Nerve Damage

  MAUDE report 20405944 ↗
• MalfunctionSep 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MAINFRAME SYSTEM HAS BEEN "UNPREDICTABLE" IN TERMS OF RESPONDING TO THE NERVE; INTERMITTENTLY UNRESPONSIVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167760 ↗
• MalfunctionSep 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem

  IT WAS REPORTED THAT WITH NIM 3,0 AFTER CHANGING PROBES, THERE IS STILL NO CONNECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154276 ↗
• InjuryAug 9, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING RIGHT PAROTIDECTOMY WITH FACIAL NERVE MONITOR NIM WAS NOT GIVING AN AUDIO TONE WHEN DISSECTING TISSUE AROUND THE PAROTID GLAND AND TRYING TO STIMULATE A NERVE. THE PROBE WAS ALSO NOT GIVING BACK A TONE WHEN TRYING TO LOCATE THE NERVE AND SURROUNDING TISSUE OF THE PAROTID. THE NURSE SAID THAT THERE WAS NERVE DAMAGE TO THE FACIAL NERVE ON THE PATIENT AND WAS GIVING A WEAK SIGNAL. SEVERITY OF THE NERVE DAMAGE WAS UNKNOWN. A STIMULUS PROBE WAS OPENED AND PLUGGED UP TO THE CONSOLE. SURGEON USUALLY DOES NOT USE PROBE THAT MUCH, BUT RELIES ON THE OTHER ELECTRODES TO "PICK UP" AND SOUND ALERTS. THE PROBE WAS USED AND DID WORK ONCE DURING THE PROCEDURE WHILE ATTEMPTING TO TROUBLESHOOT. PROBE WAS NOT SAVED AS WE DETERMINED IT WAS WORKING FINE. 6 ELECTRODES WERE USED. THE TWO IN THE ORBICULARIS, 2 AROUND THE CORNER OF THE MOUTH, AND THE OTHER TWO FOR GROUNDING ON THE RIGHT SHOULDER. APPROXIMATELY 2-3 HOURS AFTER THE COMPLETION OF THE PROCEDURE, SURGEON UPDATED THAT THE PATIENT WAS EXPERIENCING "FACIAL NERVE WEAKNES S." AT THE END OF THE DAY AT APPROXIMATELY 2:00 PM, SURGEON HAD UPDATED THAT HE THOUGHT THE INJURY WOULD ACTUALLY IMPROVE, AND MAY HAVE BEEN DUE TO THE

  Patient problems: Nerve Damage

  MAUDE report 19947509 ↗

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