NIM-Neuro® 8253402 (UDI 00613994529077)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00613994529077), received between Jun 30, 2017 and Mar 11, 2026 — classified as 2 injuries, 51 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, THE NIM MAINFRAME WAS LOOSING SIGNAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566208 ↗
• MalfunctionJan 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD NOT WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033207 ↗
• MalfunctionMar 10, 2025No Device Output; Use of Device Problem; No Device Output; Use of Device Problem

  IT WAS REPORTED THAT PRE-OP THE MAINFRAME WAS NOT GETTING RESPONSE AND NOT WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557513 ↗
• MalfunctionMar 10, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT BEFORE OPERATION, IT WAS FOUND THAT THERE WAS NO RESPONSE IN NIM MAINFRAME. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556995 ↗
• MalfunctionMar 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE CHECK, THE MAINFRAME WAS NOT WORKING PROPERLY AND HAD SENSING ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536867 ↗
• MalfunctionFeb 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS NO STIMULATION RESPONSE FOR MAINFRAME. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467428 ↗
• MalfunctionFeb 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem

  IT WAS REPORTED THAT DURING PREOP THERE WAS NO STIMULATION RESPONSE AND STIM 1 CANNOT INSERT ELECTRODE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443287 ↗
• MalfunctionFeb 12, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE MAINFRAME/PATIENT INTERFACE WAS MAKING NOISES AFTER USAGE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362500 ↗
• MalfunctionOct 21, 2024Output Problem; Output Problem

  ADDITIONAL INFORMATION RECEIVED STATING THE CAUSE OF THE ISSUE WAS IDENTIFIED AND RESOLVED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493100 ↗
• MalfunctionSep 23, 2024Break; Incorrect, Inadequate or Imprecise Result or Readings; Break; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE NIM 3.0 NEUROTRANSMITTER SIGNAL APPEARS WEAK AND NOT TRUTHFUL, BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277377 ↗
• MalfunctionSep 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT MAINFRAME WAS NOT GETTING STIMULATION AND ELECTRODE OFF ERROR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20166595 ↗
• MalfunctionAug 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE MACHINE IS PLAYING UP. CANNOT IDENTIFY THE PLACEMENT OF NEEDLES, AS SUPPOSED TO BE TICKED AS CHECK, BUT SHOWING "X". WHEN PROMPTED TO CONTINUE, IT SENSES THE NEEDLE PLACEMENTS IN THE NERVES THROUGH SOUNDS. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997881 ↗
• MalfunctionJun 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROID PROCEDURE, NIM CONSOLE LOST RESPONSE ADJUSTED THE TUBE AND GOT RESPONSE. AGAIN LOST RESPONSE READJUSTED THE TUBE AGAIN BUT STILL NO RESPONSE COULD BE OBTAINED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547445 ↗
• MalfunctionJun 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DEVICE NOT WORKING PROPERLY. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546687 ↗
• MalfunctionApr 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED THAT CUSTOMER WAS NOT SENDING UNIT IN AS THEY HAVE RECTIFIED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210659 ↗
• MalfunctionFeb 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, MAINFRAME WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737020 ↗
• MalfunctionJan 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE MAINFRAME AND PATIENT INTERFACE DOES NOT WORK CORRECTLY. SOMETIMES IT DOES NOT SENSE OR IT WORKS INCORRECTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606567 ↗
• MalfunctionJan 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE CONSOLE AND PATIENT INTERFACE WERE NOT WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463894 ↗
• MalfunctionDec 26, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION RECEIVED. TROUBLESHOOTING WAS PERFORMED BY RESTARTING THE DEVICE UNTIL IT WORKS PROPERLY. THE CUSTOMER INDICATED THE DEVICE CAN SOMETIMES NOT BE OPERATED EVEN AFTER RESTARTING. THERE WAS NOTHING DISPLAYED ON THE SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392346 ↗
• MalfunctionDec 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING INTRA-OP, THE MAINFRAME AND PATIENT INTERFACE WERE NOT WORKING CONSISTENTLY WHEN MONITORING. DEVICES WERE USING THE HEAD NECK, PAROTID 2-CHANNEL SETTING. OCULAR MONITORING WAS NOT STABLE WHEN READING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315998 ↗
• MalfunctionNov 28, 2023False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP, THE EQUIPMENT IS NOT WORKING AND DOES NOT EMIT ANY SOUND. THE CURRENT STIM DID NOT RETURN SHOW "0", INDICATING THAT THE CURRENT IS NOT BEING DELIVERED. THERE WAS NO VISUAL AND/OR AUDIBLE INDICATOR THAT ALERTED THE USER OF THE ISSUE. THE ISSUE WAS NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213831 ↗
• MalfunctionNov 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE CURRENT WAS NOT DELIVERED DURING STIMULATION. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089575 ↗
• MalfunctionOct 26, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION RECEIVED AS THE CUSTOMER RESTARTED THE DEVICE MULTIPLE TIMES UNTIL THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011221 ↗
• MalfunctionOct 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE MAINFRAME WAS NOT WORKING, THE FAULT WAS NOT SPECIFIED BY NURSES. MISSING PATIENT INTERFACE AND MUTING DETECTOR. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000376 ↗
• MalfunctionAug 31, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT NIM MONITOR MAKING INTERFERENCE NOISES EVEN AFTER TROUBLESHOOTING (CHECKING MUTING CORD, ALL PINS IN RIGHT PORT, SWITCHING ON AND OFF AGAIN). USED A DIFFERENT NIM MONITOR ON THE SAME PATIENT, USING THE SAME PINS, DIFFERENT MONITOR MADE NO NOISES. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17659674 ↗

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