NIM-Response® 8253001 (UDI 00643169547049)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169547049), received between Jan 23, 2017 and Jan 7, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026False Negative Result

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE PROCEDURE WAS THYROID CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990911 ↗
• MalfunctionMar 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS ISSUE WITH THE SYSTEM DURING THYROIDECTOMY SURGERY. AT THE TIME OF CALL, VOCALIS 1 WAS NOT PASSING ELECTRODE CHECK, INDICATED WITH A RED X. STIMULUS WAS SET TO 1.0 AND THRESHOLD WAS SET TO 120. TS HAD SITE SWITCH THE ELECTRODES INTO VOCALIS 2, AND THE RED X FOLLOWED TO VOCALIS 2. SITE NOTED THAT THESE ELECTRODES WERE CONNECTED TO A TRIVANTAGE TUBE. HOWEVER, AFTER SWITCHING THE ELECTRODES BACK TO VOCALIS 1, A GREEN CHECK MARK APPEARED AND THE SYSTEM PASSED ELECTRODE CHECK. AT THIS POINT, THE SURGEON NOTED THAT WHEN STIMMING, VOCALIS 1 WAS JUMPING OVER 3,000 MICROVOLTS. VOCALIS 2 DID NOT HAVE THE SAME ISSUE AND HOVERED AROUND 150 TO 200 MICROVOLTS WHEN STIMMING. TS SUGGESTED THEY RESEAT THE ELECTRODES, CHECK FOR PRESSURE ON THE ELECTRODE WIRES, AND RESEAT THE TUBE WITHIN THE PATIENT. THE SITE PERFORMED ALL AND NOTED THAT THEY WERE STILL RECEIVING OVER 3,000 MICROVOLTS WHEN STIMMING. WHEN EVENT CAPTURE WAS TURNED OFF, THE RESTING MICROVOLTS HOVERED AROUND 20. THE SITE DECIDED TO REINTUBATE THE PATIENT AND ENDED THE CALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER NIM SYSTEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661027 ↗
• MalfunctionMar 14, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT THERE WAS ISSUES WITH THE NIM RECOGNIZING NERVE. THERE WAS NO SOUND THAT COMES OUT SOMETIMES. WHEN SWITCHED TO A DIFFERENT NIM, THE NIM WILL WORK AS EXPECTED WITH THE NERVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603234 ↗
• MalfunctionOct 14, 2024False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DEVICE WAS HAVING ISSUES WITH CHANNEL 3 AND 4. DEVICE SHOULD INDICATE NON-NERVE BUT WILL ONLY DISPLAY NERVE WHEN IN USE. THIS WAS CONFIRMED BY THE ENT REP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436745 ↗
• MalfunctionMar 6, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT, DURING INTRA-OPERATIVE WHEN USING THE MAINFRAME SYSTEM ON A PATIENT SIMULATOR, THE SYSTEM PICKS UP SIGNAL AS INTENDED. HOWEVER, WHEN USING SYSTEM ON PATIENT, VERY LITTLE SIGNAL WOULD PICK UP. HCP TRIED INCREASING STIMULATION VALUE, AS WELL AS DECREASING THRESHOLD AND ISSUE DID NOT RESOLVE. THE PROCEDURE HAS BEEN EXTENDED LESS THAN 1 HOUR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848239 ↗
• MalfunctionMar 13, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING THE CASE, THE ELECTRODES FAILED TO BE RECOGNIZED BY THE NIM. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528288 ↗
• MalfunctionOct 28, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE MACHINE WAS NOT RESPONDING EVEN AFTER CHANGING THE PROBE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15688966 ↗
• MalfunctionAug 3, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT INTERFERENCE WITH PATIENT INTERFACE AND STIMULATION NOT WORKING. NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160769 ↗
• MalfunctionDec 8, 2020Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER REPORTED THAT THE MAINFRAME WAS NOT WORKING, TRIED CHANGING OUT A NEW INTERFACE CABLE AND STILL HAD ISSUES. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968102 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE DEVICE WAS NON SPECIFIC BROKEN. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10660848 ↗
• MalfunctionJan 8, 2020Failure to Read Input Signal; Use of Device Problem; Failure to Read Input Signal; Use of Device Problem

  A HEALTH CARE PROVIDER REPORTED THAT THE MAINFRAME WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564335 ↗
• InjuryMay 17, 2019Failure to Read Input Signal; Failure to Read Input Signal

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING WHILE THE SITE WAS SETTING UP FOR A PAROTID SURGERY WITH A PATIENT PRESENT AND UNDER ANESTHESIA. THE FUSES WERE REPLACED BUT WHEN THE SYSTEM WAS TESTED WITH A PATIENT SIMULATOR, BOTH CHANNEL 1 AND 3 WERE NOT FUNCTIONAL. THE SURGERY WAS CANCELLED AND WILL BE RESCHEDULED, AS IT NEEDS THE USE OF ALL 4 CHANNELS ON THE SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619248 ↗
• MalfunctionJan 8, 2019Failure to Read Input Signal; Noise, Audible; Failure to Read Input Signal; Noise, Audible

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THERE WAS A CONSTANT NOISE FROM THE MAINFRAME DURING A THYROID PROCEDURE. THE ANESTHESIA CONFIRMED THE PROPER PLACEMENT AND RECHECKED; THE MAINFRAME WAS PLUGGED INTO A DEDICATED OUTLET AND AWAY FROM THE BOVIE UNIT. THE MUTING DETECTOR WAS PROPERLY PLACED. AFTER CHECKING THE ELECTRODE CHECK, THERE WERE NO GREEN CHECK MARKS. WHEN THE PARAMETER DETAILS WAS CHECKED, IT WAS A HIGH OF 30 AND LOW OF 0. THE ANESTHESIOLOGIST SAID HE WAS GETTING A LIGHT SHOCK WHEN HE WAS MANIPULATING THE FIRST TUBE SO HE THOUGHT THERE WAS A CIRCUIT ISSUE. AFTER THE TUBE WAS CHANGED OUT AND THE PATIENT WAS RE-INTUBATED WITH THE NEW TUBE, EVERYTHING WORKED. THERE WAS A PROCEDURE DELAY OF LESS THAN 1 HOUR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227702 ↗
• MalfunctionOct 12, 2018Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT ELECTRODE #1 DID NOT WORK WITH THE PATIENT INTERFACE. THE DEVICE WAS TESTED WITH THE PATIENT SIMULATOR AND THE ELECTRODES CONNECTED TO #2 WORKED BUT THERE WAS NO RESPONSE WHEN CONNECTED TO #1. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7962843 ↗
• MalfunctionSep 10, 2018Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT WHILE DOING THE ELECTRODE CHECK THERE WERE X'S DURING THE THYROIDECTOMY PROCEDURE. THE SITE SWITCHED OUT THE PATIENT INTERFACE AND IT ENDED UP WORKING; HOWEVER, WHEN THEY WERE STIMULATING DURING THE PROCEDURE THEY ALL OF A SUDDEN LOST STIMULATION. THE MANUFACTURER REPRESENTATIVE TESTED OUT THE SYSTEM IN ANOTHER ROOM AND WAS GETTING A RESPONSE ON ALL THE CHANNELS. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7860136 ↗
• MalfunctionJan 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE USER WAS NOT GETTING A RESPONSE FROM THE NIM 3.0 DEVICE WHEN TOUCHING THE NERVE. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE WITH NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6271016 ↗

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