NIM-Neuro® 8253402 (UDI 00643169230378)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169230378), received between Dec 20, 2016 and Jan 16, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIM MAINFRAME SENOR CONTACT WAS NOT GOOD. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096456 ↗
• MalfunctionDec 12, 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 OPERATIVELY, THE PROGRAM STARTS, BUT THE ELECTRODES ON THE PATIENT ARE NOT RECOGNIZED DESPITE THE MACHINE SEARCHING FOR A LONG TIME. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789806 ↗
• MalfunctionDec 8, 2025False Negative Result; Application Program Freezes or Fails to Launch; False Negative Result; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT INTRAOPERATIVELY DEVICE DOES NOT WORK AND HAD PROBLEMS, REP. DID A CHECK WITH THE PATIENT SIMULATOR AND SOMETIMES THE NIM DIDN¿T RECOGNIZE THE SIGNAL, THE RESPONSE WASN'T GOOD. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753050 ↗
• MalfunctionAug 14, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING PRE-OP, THE MAINFRAME FAILED TO START. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801839 ↗
• MalfunctionJun 22, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PRE OP, DEVICE NOT GETTING ON. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22304563 ↗
• MalfunctionJun 5, 2025False Negative Result; Inappropriate Audible Prompt/Feedback; False Negative Result; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT BEFORE OPERATION, THE MAINFRAME HAD NOISE AND SOMETIMES NERVES CANNOT BE DETECTED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147678 ↗
• MalfunctionJun 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT NIM 3.0 HAD BREAKDOWN AND HAD INCONSISTENT READINGS, ELECTRODES FIRING INTERMITTENTLY WITHOUT PHYSICAL TRIGGERING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130025 ↗
• MalfunctionMar 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET UP, THE NIM MAINFRAME WAS UNABLE TO DETECT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604449 ↗
• MalfunctionNov 6, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, NIM SYSTEM WAS NOT DETECTING FACIAL NERVE. THE ELECTRODES WERE PLACED AS PER INSTRUCTION AND WHEN CONNECTED TO THE NIM IT WAS NOT WORKING. THE USER THEN PLACED THE EXACT SAME ELECTRODES INTO THE BACKUP DEVICE AND COULD THEN DO NERVE MONITORING. NO MUSCLE RELAXANTS WAS USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20617343 ↗
• MalfunctionOct 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFO RECEIVED STATING THAT THE EVENT OCCURRED DURING SET UP, THE ELECTRODE CHECK KEPT ON FAILING DESPITE ALL THE TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437597 ↗
• MalfunctionAug 26, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT BEFORE OPERATION MAINFRAME DOES NOT BOOT UP. THE DEVICE GOT SHUTDOWN AND TOUCHSCREEN WENT WRONG. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061939 ↗
• MalfunctionApr 2, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE DEVICE HAD NOT RELAYING SIGNAL FROM INTERFACE MODULE TO MONITOR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016988 ↗
• MalfunctionJan 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING NORMAL USE, THE STIMULATION WAS NOT WORKING WELL WITH SIGNAL LOSS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569477 ↗
• MalfunctionDec 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING PRE-OP MAINFRAME WAS NOT WORKING OPTIMALLY. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308650 ↗
• MalfunctionDec 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT MAINFRAME WAS NOT RESPONDING, PRIOR TO USE. THERE IS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272123 ↗
• MalfunctionAug 28, 2023False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Noise, Audible; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Noise, Audible

  CUSTOMER TRIED DISCONNECTING LEADS AND RE-ATTACHING, AND TURNING UNIT OFF AND ON AGAIN. THE PROCEDURE WAS COMPLETED BY REPLACEMENT PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630517 ↗
• MalfunctionFeb 7, 2023Device Sensing Problem; Device Sensing Problem

  ON FOLLOW-UP IT WAS REPORTED THAT EVENT OCCURRED INTRA-OP, WITHOUT AUDIBLE ALARMS, THE ABSENCE OF A BIPHASIC CURVE WAS OBSERVED AND ELECTRODES WERE REPOSITIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314150 ↗
• MalfunctionJun 28, 2022Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846992 ↗
• MalfunctionJun 6, 2022Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE VAGUS STIMULATION WAS NOT FUNCTIONING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600459 ↗
• MalfunctionFeb 17, 2022Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT IT DOES NOT RECOGNIZE THE ELECTRODES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13547682 ↗
• MalfunctionJul 16, 2020Failure to Sense; Use of Device Problem; Failure to Sense; Use of Device Problem

  ON FOLLOW-UP, IT WAS REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT IT WAS NOT POSSIBLE TO STIMULATE DURING THE PROCEDURE. THE DEVICE WAS JUST USED FOR MECHANICAL STIMULATION PREVENTION. THERE WAS NO ERROR CODES OR ANY VISUAL/AUDIBLE INDICATOR THAT ALERTED THE USER OF THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10282913 ↗
• MalfunctionApr 1, 2020Break; Break

  THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909898 ↗
• MalfunctionDec 18, 2019Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED THAT DEVICE WAS RETURNED FOR PREVENTIVE MAINTENANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491654 ↗
• MalfunctionMar 12, 2019Noise, Audible; Noise, Audible

  THE HEALTH CARE PROVIDER REPORTED THAT THE MAINFRAME AND INTERFACE HAD A LOUD NOISE DURING THE PROCEDURE. THE INITIAL CHECK OF THE MACHINE, THE TICKS WERE ON AND OFF. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413110 ↗
• MalfunctionNov 9, 2018Electrical /Electronic Property Problem; Failure to Power Up; Use of Device Problem; Electrical /Electronic Property Problem; Failure to Power Up; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT THE FUSES OF THE DEVICE BURNED DURING THE PROCEDURE, AFTER REPLACING THE FUSES OF THE DEVICE WITH ORIGINAL FUSES, THE DEVICE WAS STILL NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8054475 ↗

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-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