NIM-Response® 8253200 (UDI 00613994499615)Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 00613994499615), received between Dec 12, 2016 and May 14, 2026 — classified as 113 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (48 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 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP, THE EMG OPTION DOES NOT TURN ON BEFORE STARTING WORK, THE PROCEDURE WAS COMPLETED WITH AN OTHER NERVE MONITOR AND THE EMG TUBE WAS WORKING FINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167994 ↗
• MalfunctionMar 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, PATIENT INTERFACE WAS GIVING NO STIMULATION RESPONSE, CHANNEL 1 SELF-CHECK FAILED. NO ANESTHESIA, MUSCLE RELAXANT ON BOARD, OR TOO MUCH FLUID IN THE FIELD WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605936 ↗
• MalfunctionFeb 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, NO STIMULATION RESPONSE FROM PATIENT INTERFACE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425145 ↗
• MalfunctionDec 26, 2025Intermittent Continuity; Noise, Audible; Intermittent Continuity; Noise, Audible

  IT WAS REPORTED THAT PRE-OP, THE NIM 3.0 PATIENT INTERFACE HAD RATTLING SOUND FROM INSIDE THE MODULE. AND INTERMITTENTLY CUT OUT WHEN USING SIMULATOR BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895791 ↗
• MalfunctionDec 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SETUP, THE PATIENT INTERFACE DOESN'T WORK. DATA CONNECTIVITY ISSUE FROM SENSOR TO INTERFACE AND MONITOR SENSORS CONNECTED TO THE PATIENT, PLACED UNDER THE SKIN DO NOT TRANSMIT INFORMATION TO THE COMPUTER, NONE SOUND SIGNALING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861394 ↗
• MalfunctionDec 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT HALFWAY THROUGH THE SURGERY, AFTER STIMULATION WITH THE PROBE, THERE WAS NO RESPONSE (NEGATIVE OR POSITIVE). THE ERROR PERSISTS EVEN AFTER CHANGING THE PROBE. IT COULD BE THE COMMAND FUSES. THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCT. THE PROCEDURE WAS COMPLETED WITHOUT MONITORIZATION. THE USER DOES NOT CONFIRMS THERE WAS SOMETHING CAUSING A LACK OF RESPONSE (I.E. ANESTHESIA, MUSCLE RELAXANT ON BOARD, OR TOO MUCH FLUID IN THE FIELD. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764893 ↗
• MalfunctionDec 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE HAD NO RESPONSE. THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739438 ↗
• MalfunctionNov 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT HALFWAY THROUGH THE SURGERY, AFTER STIMULATION WITH THE PROBE, THERE WAS NO RESPONSE (NEGATIVE OR POSITIVE). THIS HAD HAPPENED BEFORE. THE ERROR PERSISTS EVEN AFTER CHANGING THE PROBE. IT COULD BE THE COMMAND FUSES. THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCT. THE PROCEDURE WAS COMPLETED WITHOUT MONITORIZATION. THE USER DOES NOT CONFIRMS THERE WAS SOMETHING CAUSING A LACK OF RESPONSE (I.E. ANESTHESIA, MUSCLE RELAXANT ON BOARD, OR TOO MUCH FLUID IN THE FIELD. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677451 ↗
• MalfunctionOct 17, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRE-OP, THERE WAS NO STIMULATION RESPONSE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320222 ↗
• MalfunctionAug 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, WHEN  PATIENT LEADS CONNECTED TO THE MONITOR DOES NOT WORK HOWEVER, WHEN THE SAME LEADS ARE CONNECTED TO A DIFFERENT MONITOR, THEY FUNCTION CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. PROCEDURE WAS COMPLETED WITH THE BACK UP DEVICE. WHEN THE TECHNICIAN PERFORMED TROUBLESHOOTING WITH THE OTHER LEAD , THE ISSUE WAS NOT DUPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872285 ↗
• MalfunctionJul 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT INTERFACE SIGNAL OF ELECTRODE DID NOT COME THROUGH. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563006 ↗
• MalfunctionJul 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING OPERATION, THE PATIENT INTERFACE WAS NOT WORKING. THE ISSUE WAS NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED WITH THE BACKUP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455593 ↗
• MalfunctionApr 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE NIM 3.0 PATIENT INTERFACE HAD NO STIM RESPONSE. THERE WAS NO STIMULUS DELIVERY TONE HEARD AND NO DISPLAY ON STIM RETURN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871716 ↗
• MalfunctionMar 28, 2025Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, PATIENT INTERFACE FALSE CONTACT AT CHANNEL 1. ARTIFACT AND LOTS OF PARASITIC SIGNALS DURING TEST WITH SIMULATOR ON CHANNEL 1. CHANNEL 2 WAS POSSIBLY WITH SAME DEFECT. CHANNELS 3 AND 4 WORK WELL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21716421 ↗
• MalfunctionMar 14, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT, BEFORE OPERATION, PATIENT INTERFACE HAD NO RESPONSE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604093 ↗
• MalfunctionMar 7, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRIOR TO USE, DEVICE WAS NOT WORKING. COULDN¿T RECEIVE STABLE SIGNAL. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546701 ↗
• MalfunctionFeb 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TESTING/MAINTENANCE, STIM 1 WAS FAULTY AND HAVING INTERMITTENT STIMULATING. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466216 ↗
• MalfunctionFeb 25, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT PRE-OP, THE NIM PATIENT INTERFACE HAD NO SIGNAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462434 ↗
• MalfunctionFeb 25, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHEN USED IN INSPIRE SETTINGS, IT IS NOT PICKING ANY SIGNAL. USED A DIFFERENT PATIENT INTERFACE BOX AND THE ISSUE RESOLVED. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456128 ↗
• MalfunctionNov 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE MALFUNCTION WAS NOT SPECIFIED BY CUSTOMER. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20803441 ↗
• MalfunctionNov 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE OP, DEVICE WAS NOT STIMULATING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649624 ↗
• MalfunctionOct 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE STAGE, THE PATIENT INTERFACE DEVICE DOES NOT WORKED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381798 ↗
• MalfunctionJul 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE STIM 1 INPUT PORT WAS NOT RESPONSIVE. THE DEVICE DISPLAYED GREEN CHECK MARKS WHEN THE CABLES WERE PLUGGED TO THE SIMULATOR. THE PROBE WAS REPLACED BUT THE ISSUE COULD NOT BE RESOLVED. THE USER PROCEEDED WITH THE CASE BY USING THE STIM 2 PORT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739461 ↗
• MalfunctionJun 25, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT DURING INTRA-OP, THE NIM PATIENT INTERFACE HAD BIG INTERFERENCE. THE NOISE ON SCREEN WAS CALLED AS INTERFERENCE AND NO INTERFERENCE FROM ANY ELECTROSURGICAL UNIT. NORMAL MONITORING WAS NOT POSSIBLE. VISUAL/AUDIBLE INDICATOR ALERTED THE USER OF THE ISSUE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604601 ↗
• MalfunctionMar 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED THAT, PATIENT INTERFACE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848598 ↗

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-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