NIM-Response® 8253200 (UDI 00643169782440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00643169782440), received between Feb 9, 2018 and Aug 4, 2026 — classified as 1 injury, 149 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (82 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50126506 ↗
• MalfunctionJun 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THE NIM PATIENT INTERFACE WAS NOT PROVIDING STIMULATION RESPONSE. SYSTEM PASSED ELECTRODE CHECK BEFORE ENTERING INTO THE MONITORING SCREEN. RETURN STIMULUS WAS DISPLAYED AS "0", THERE WAS NO AUDIBLE FEEDBACK NOR A WAVEFORM GOT DISPLAYED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617696 ↗
• MalfunctionJun 15, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT PRE-OP, THE SIGNAL INTERFERENCES WERE OBSERVED. NO TROUBLESHOOTING WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498272 ↗
• MalfunctionMay 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THE PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340614 ↗
• MalfunctionMay 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THE MAINFRAME HAD NOT STIMULATION RESPONSE AND PROCEDURE WAS COMPLETED WITH THE BACK UP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158763 ↗
• MalfunctionApr 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THERE WAS NO STIMULATION RESPONSE FROM PATIENT INTERFACE. THERE WAS DAMAGE TO THE STIM 1 CHANNEL AND ALL OTHER STIM CHANNELS WERE WORKING AS EXPECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24825157 ↗
• MalfunctionMar 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604092 ↗
• MalfunctionFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THE PI WAS NOT STIMULATING AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439812 ↗
• MalfunctionFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THE PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289085 ↗
• MalfunctionFeb 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THERE WAS NO STIMULATION RESPONSE. THE STIM RETURN, LOCATED UNDER THE STIMULUS SETTING ON THE MONITOR, DISPLAYED 0. THERE WAS NO STIMULUS DELIVERY TONE AND WAVEFORM DISPLAYED WHILE STIMULATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256358 ↗
• MalfunctionDec 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THE PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919401 ↗
• MalfunctionDec 22, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING INTRA-OP, THERE WAS NO NERVE RESPONSE. THERE WAS NO STIMULUS DELIVERY SOUND WHEN TRYING TO STIMULATE. THE PROCEDURE WAS COMPLETED USING ANATOMICAL LANDMARKS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861901 ↗
• MalfunctionDec 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING OPERATION, THE PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740331 ↗
• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, PATIENT INTERFACE WAS GIVING NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654152 ↗
• MalfunctionOct 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433463 ↗
• MalfunctionOct 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PATIENT INTERFACE CABLE SHORTED , WORKS INTERMITTENTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377991 ↗
• MalfunctionOct 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT INTERFACE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347375 ↗
• MalfunctionSep 19, 2025Break; Incorrect, Inadequate or Imprecise Result or Readings; Break; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIM 3.0 PI HAD CONNECTOR BROKEN. THERE¿S NO STIMULATION RESPONSE ERROR BECAUSE OF CONNECTOR BROKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093137 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION THE PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892069 ↗
• MalfunctionAug 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE ON THE PATIENT, THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779966 ↗
• MalfunctionAug 7, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING INTRA-OP, THE NIM 3.0 PATIENT INTERFACE HAD NO SIGNAL FROM ELECTRODE/STIM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735617 ↗
• MalfunctionJul 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION THE PATIENT INTERFACE BOX HAD NO STIMULATION RESPONSE. DURING NERVE STIMULATION ATTEMPTS, NO RESPONSE WAS DETECTED ON THE MONITOR, THE STIM RETURN SHOWED "0," NO "STIMULUS DELIVERY" TONE WAS HEARD, AND NO WAVEFORM WAS DISPLAYED. THE PROCEDURE WAS COMPLETED WITH THE OTHER EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665990 ↗
• MalfunctionJul 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SETUP, THERE WAS NO STIMULATION RESPONSE FROM THE NIM DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22661789 ↗
• MalfunctionJul 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD NO STIMULATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528445 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIM 3.0 SYSTEM PASSED THE TEST BUT DID NOT FUNCTION CORRECTLY ON THE PATIENT. THE TESTS FAILED TO TURN GREEN WHEN ACTUAL CONSUMABLES WERE CONNECTED TO THE PATIENT, DESPITE TRYING MULTIPLE SETS OF CONSUMABLES. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517991 ↗

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