NIM-Response® 8253001 (UDI 00613994499714)Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00613994499714), received between Dec 6, 2016 and Sep 18, 2026 — classified as 11 injuries, 143 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (27 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 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026False Negative Result

  It was reported that during Goiter removal procedure, the system is "not reading correctly"-- no clarification could be confirmed. Site swapped to another system to complete the surgery. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813520 ↗
• MalfunctionSep 1, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541769 ↗
• MalfunctionJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50048736 ↗
• MalfunctionMar 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, NIM CONSOLE WAS PROVIDING AN INTERMITTENT "ELECTRODE OFF" MESSAGE AS WELL AS RANDOM FEEDBACK WHILE IN SURGERY. SITE WAS USING AN EMG TUBE. SITE HAD REBOOTED NIM WITH NO CHANGE. DURING THE ELECTRODE CHECK THEY FOUND THAT THE RETURN AND STIM 1 ELECTRODES PASSED WHILE THE VOCALIS 1 AND 2 ELECTRODES WERE INTERMITTENT. SITE WAS ABLE TO TEMPORARILY PASS ELECTRODE CHECK BY ADJUSTING THE TUBE PLACEMENT. AFTER PASSING THEY WOULD STILL SEE INTERMITTENT "ELECTRODE OFF" AND RANDOM FEEDBACK IN MONITORING. SITE RESEATED ELECTRODES INTO PI BOX, AND CONFIRMED NO WIRES PASSING OVER THAT OF THE NIM. SITE CONFIRMED TUBE WAS NOT KINKED. AFTER RESEATING THE PI BOX INTO THE BACK OF THE CONSOLE THEY WERE ABLE TO CONTINUE. ELECTROSURGICAL DEVICE WAS BEING USED DURING THE EVENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674402 ↗
• 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 24615233 ↗
• MalfunctionMar 16, 2026False Negative Result; Inappropriate Audible Prompt/Feedback; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT NIM CONSOLE "TAP TEST" DOESN¿T RESPOND AND THAT THE SCREEN FREEZES. ALSO, WHEN NOT STIMULATING AND A BOVIE TO CAUTERIZE AND USER COULD HEAR THE NIM PICKING UP SOME RESPONSES FROM IT WITH USING THE MUTING CLAMP AND WITHOUT THE MUTING CLAMP. NO ERROR MESSAGES APPEARED THERE WAS A DELAY OF LESS THAN 1 HOUR IN PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603827 ↗
• MalfunctionMar 12, 2026False Negative Result

  IT WAS REPORTED THAT INTRA-OP, WHEN STIMMING THE NERVE, THERE WERE NO VISUAL OR AUDIO RESPONSE FROM THE CONSOLE. THEY TRIED ADJUSTING THE ELECTRODES ON THE PATIENT BUT THE ISSUE WAS NOT RESOLVED. THEY SWITCHED TO ANOTHER SYSTEM (KEPT THE ORIGINAL STIMULATOR) AND THE ISSUE WAS NOT REPLICATED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578019 ↗
• MalfunctionFeb 15, 2026Computer Software Problem; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED DURING USE THAT THE DEVICE HAD THE SYSTEM BEGAN TO BEEP BEFORE SHUTTING ITSELF DOWN SHORTLY LATER. WHEN SITE REBOOTED THE SYSTEM, THE SYSTEM BOOTED TO A BLANK WHITE SCREEN. ISSUE PERSISTED ACROSS MULTIPLE OUTLETS. TROUBLESHOOTING WAS PERFORMED PROBABLE CAUSE: INTERNAL SYSTEM ERROR. SYSTEM WAS END OF GUARANTEED SERVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341749 ↗
• MalfunctionJan 29, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING SET UP, WHEN LEADS ARE PLUGGED INTO VOCALIS 2, THE SYSTEM MAKES A CONTINUOUS BEEP. WHEN THEY PLUG THE LEADS TO THE OTHER CHANNELS, THEY WORK AS DESIGNED. THE PATIENT INTERFACE HAD RED PORT LOOSE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206947 ↗
• MalfunctionDec 30, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT SYSTEM DISPLAYED EXCESSIVE NOISE AND EMG WAVES. BIOMED CONFIRMED THAT AN ELECTROSURGICAL UNIT WAS BEING USED IN THE OR, BUT A MUTING CABLE WAS IN PLACE. NO PATIENT DEMOGRAPHICS OR SURGICAL DETAILS WERE AVAILABLE TO BIOMED. THE ISSUE AFFECTED ALL PI CHANNELS. WHEN ONLY THE CONSOLE WAS REPLACED (USING THE SAME PI BOX AND SETUP), THE PROBLEM DID NOT RECUR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931636 ↗
• MalfunctionDec 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE COMPLETED WITH REPORTED PRODUCT. THE THYROID SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894503 ↗
• MalfunctionNov 21, 2025Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA OP, SYSTEM'S STIMMING SIGNALS INTERMITTENTLY CUT IN AND OUT AND THAT THERE IS SIGNAL INTERFERENCE BY OTHER SYSTEMS IN THE OPERATING ROOM. THIS OCCURS WHEN BOVEEING BUT IS ALTERNATED WITH STIMMING AND NOT AT THE SAME TIME AND THE BOVEE HAS A MUTING CLAMP. SYSTEM IS PLUGGED INTO A BOOM, TESTED THE SYSTEM WITH A PATIENT SIMULATOR AND ADJUSTING MUTING AND THRESHOLD SETTINGS, THE MUTE DETECTOR PORT VISUALLY APPEARS DAMAGED. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614132 ↗
• MalfunctionNov 6, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE DURING CRANIOTOMY PROCEDURE, SYSTEM CONSISTENTLY FAILS THE STIM 1 ELECTRODE CHECK. AS A RESULT, THE SITE HAS SWITCHED TO STIM 2 FOR USE IN SURGERY. THE NIM WAS NOT MEASURING ANY NERVE RESPONSE. THE SECOND ONE WAS BROUGHT IN AND THAT DID NOT MEASURE ANY NERVE RESPONSE EITHER. PROBES WERE SWITCHED OUT AS WELL. ELECTRODES WERE THE ONLY ITEMS NOT REPLACED IN THE CASE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493925 ↗
• MalfunctionOct 15, 2025False Negative Result; Application Program Freezes or Fails to Launch; False Negative Result; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THERE ARE INTERMITTENT RESPONDING ISSUES. TRIED DIFFERENT PROBES WITH NO RESOLUTION WHEN LOOKING FOR NERVE. THEY ONLY GET A NEGATIVE RESPONSE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297839 ↗
• MalfunctionAug 11, 2025Signal Artifact/Noise; Signal Artifact/Noise

  ADDITIONAL INFORMATION RECEIVED, FINISHED THE CASE WITHOUT MONITORING THE NERVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769292 ↗
• MalfunctionJun 23, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT PRE OP, SYSTEM BOOTS UP TEMPORARILY THEN GOES TO BLACK AND WHITE SCREEN. THE ISSUE SEEMS TO BE INTERMITTENT. SYSTEM IS WORKING ON UPGRADING SYSTEM. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306860 ↗
• MalfunctionJun 20, 2025Computer Software Problem; Failure to Power Up; Computer Software Problem; Failure to Power Up

  IT WAS REPORTED THAT HE SCREEN WILL OCCASIONALLY GIVE A NO COMMUNICATION ERROR AND THEN BEEP LIKE IT HAS BEEN UNPLUGGED. THE SITE HAS REBOOTED THE SYSTEM SEVERAL TIMES AND SWITCHED OUTLETS. WHEN THIS HAPPENS, THE MONITOR COLOR CHANGES SLIGHTLY AND FORCES THE SYSTEM TO SHUT DOWN. THE ERROR SEEN READS THE FOLLOWING: "NO COMMUNICATION WITH DSP4, NO REPLY, Q COUNT - 0, MONITORING CANNOT CONTINUE. PLEASE RESTART THE SYSTEM." THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294915 ↗
• MalfunctionMay 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO TESTING ,MAINFRAME HAD BURNING SMELL. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22120748 ↗
• MalfunctionApr 1, 2025False Positive Result; Inappropriate Audible Prompt/Feedback; False Positive Result; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT, WHILE IN TYMPANOMASTOIDECTOMY SURGERY, THE SYSTEM WAS GIVING OFF NOISE AND RESPONSE WHILE THE SURGEON WAS NOT STIMMING. THE SURGEON WAS ACTIVELY USING A BOVIE ON THE PATIENT DURING THIS TIME. SITE INCREASED THE THRESHOLD FROM 100UV TO 105UV. THE ISSUE PERSISTED. THE SURGERY WAS COMPLETED WITHOUT THE NIM DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739486 ↗
• MalfunctionMar 6, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING THYROIDECTOMY, SITE WAS NOT GETTING ANY RESPONSE FROM THE NERVE. UPON TROUBLESHOOTING IT WAS DETERMINED THAT STIM 1 WAS NOT OUTPUTTING ANY STIMULUS. RECOMMENDED SWITCHING TO STIM 2 AND CHECKING THE FUSES AFTER THE CASE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536819 ↗
• MalfunctionMar 5, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT THIS SYSTEM WAS UNRESPONSIVE DURING A PAROTIDECTOMY PROCEDURE. STIM WAS BEING DELIVERED. AUDIO INDICATORS ALERTED THE USER OF THE ISSUE. USER WAS UNSURE IF IT WAS A CONNECTION ISSUE, RESEATED ALL CONNECTIONS WITH NO RESOLUTION, WAS NOT INTERMITTENT, THERE WAS NO RESPONSE AT ALL. SWAPPED CONSOLE AND INTERFACE BOX WITH NO CHANGE. ADJUSTED THRESHOLD TO 80, TAPPED ON THE MUSCLE THAT WAS INNERVATED AND USED STIM PROBE, CONSOLE SHOWS THAT STIM IS DELIVERING APPROPRIATE SIGNAL, PASSING ELECTRODE CHECK. REPLACED ELECTRODES CHECKING PLACEMENT WITH NO CHANGE. AREA WHERE ELECTRODES ARE PLACED IS NOT BEING IRRIGATED, NO PARALYZING ANESTHETIC IS IN USE. THE PROCEDURE WAS DELAYED FOR LESS THAN AN HOUR AND WAS ABORTED AFTER PATIENT WAS UNDER FOR 30-40 MINUTES. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21522577 ↗
• MalfunctionFeb 26, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING A THYROIDECTOMY, THE MAINFRAME WAS MAKING NOISE EVERY TIME ANY TISSUE WAS STIMULATED. SITE ATTEMPTED TO PULL THE ET TUBE BACK WITHOUT EFFECT. THRESHOLD LOWERED FROM 130 UV TO 100 UV WITHOUT EFFECT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466851 ↗
• MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING FUNCTION ENDOSCOPIC SINUS SURGERY PROCEDURE NOTED THAT THE SYSTEM'S #2 ELECTRODE HAD A RED X WHEN IN ELECTRODE CHECK. HCP RESEATED THE ELECTRODE AND ELECTRODE CHECK PASSED AND NOTED THAT WHILE IN SURGERY, THE #2 ELECTRODE WOULD INTERMITTENTLY SWITCH BETWEEN A RED X AND GREEN CHECK MARK. REBOOTED THE SYSTEM AND UPON BOOTUP, THE SYSTEM DISPLAYED A WATCHDOG ERROR. THE ERROR EVENTUALLY CLEARED ITSELF, BUT WHEN PROCEEDING BACK INTO MONITORING, NOTED THAT THE SYSTEM DID NOT PICK UP STIMULATION FROM THE SURGEON. HCP UNABLE TO CONFIRM WHAT THE MICOVOLT READINGS WERE AT THIS TIME.A NIM VITAL WAS BROUGHT IN TO REPLACE THIS SYSTEM AND THE SITE PROCEEDED WITH SURGERY WITHOUT INCIDENT AND EXTENDED LESS THAN ONE HOUR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400000 ↗
• MalfunctionJan 10, 2025Signal Artifact/Noise; Inappropriate Audible Prompt/Feedback; Signal Artifact/Noise; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE THE STAFF TURN ON THE NIM 3.0, THE PATIENT ECG SCREEN SHOW A FLUTTER. A CARDIOLOGIST WAS CONSULTED AND THE END VERDICT WAS ARTIFACT CREATED BY THE NIM TUBE OR NIM 3.0 DEVICE. THE PROCEDURE WAS REALIZED WITH THE FLUTTER LIKE ECG ALL DURING THE SURGERY. AS SOON AS THE STAFF TURN OFF THE NIM 3.0, THE FLUTTER ARTIFACTS DISAPPEARED FROM THE ECG SCREEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122049 ↗
• MalfunctionDec 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SURGEON WAS STIMULATING THE VAGUS NERVE BUT WOULD SEE RESPONSE IN A DIFFERENT CHANNEL THAN EXPECTED (FOR EXAMPLE STIMULATING AT 1 BUT SEEING IT IN 2). THEN WHEN STIMULATING WHERE THEY EXPECTED FOR THE OTHER CHANNEL, THEY WERE SEEING NO RESPONSE. PATIENT PRESENT. UNKNOWN DELAY. AFTER SURGERY AND STATED THAT WHEN REMOVING ELECTRODES FROM ANY CHANNEL THE SYSTEM WOULD CONTINUOUSLY BEEP INSTEAD OF MOVING TO NO ELECTRODE. ALSO, WHEN REBOOTING THE DATE AND TIME WOULD RESET. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033935 ↗

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