NIM-Response® 8253200 (UDI 00643169283275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00643169283275), received between Dec 27, 2016 and Sep 17, 2026 — classified as 1 injury, 99 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (33 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 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Inappropriate Audible Prompt/Feedback

  It was reported that pre op there was a great interference occurred from the patient interface. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798285 ↗
• MalfunctionJun 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP, THE PATIENT INTERFACE HAD NO RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498386 ↗
• MalfunctionJun 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, NIM SYSTEM HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494700 ↗
• MalfunctionMay 8, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE NIM 3.0 HAD NO STIM RESPONSE. THERE WAS RETURN CURRENT. ISSUE NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25120157 ↗
• MalfunctionMay 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108493 ↗
• MalfunctionMar 23, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING OPERATION THE PI BOX WHEN PLUGGING IN IT DOES NOT RESPOND. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659228 ↗
• MalfunctionFeb 13, 2026False Negative Result; Connection Problem

  IT WAS REPORTED THAT PRE-OP, NIM PATIENT INTERFACE HAD NO STIM RESPONSE. POOR CONTACT AT STIM PORT, NO IRRITATION REACTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330280 ↗
• MalfunctionDec 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, IT WAS FOUND THAT THERE IS NO STIMULATION RESPONSE ( USED THE SIMULATOR TEST MACHINE BEFORE OPERATION , CONTACT SIGNAL IS WEAK ). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815774 ↗
• MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE OPERATION, THE PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THE STIM RETURN, LOCATED UNDER THE STIMULUS SETTING ON THE MONITOR, SHOWS 0. THERE IS NO STIMULUS DELIVERY TONE HEARD WHEN ATTEMPTING TO STIMULATE THE NERVE. THERE IS NO WAVEFORM DISPLAYED ON THE MONITOR WHEN ATTEMPTING TO STIMULATE THE NERVE. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712370 ↗
• MalfunctionNov 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTRODE BOX WAS DEFECTIVE, THE MAIN DEVICE ITSELF WAS WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663556 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OPERATION, THE PATIENT INTERFACE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994859 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, IT WAS FOUND THAT THE DEVICE DOES NOT STIMULATE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892737 ↗
• MalfunctionMay 9, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRE-OP, NIM PATIENT INTERFACE HAD NO STIMULATION RESPONSES. STIM1 CHANNEL SELF-TEST CAN PASS, BUT THERE IS NO STIMULUS RESPONSE. THE PROCEDURE WAS COMPLETED USING BACK UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991391 ↗
• MalfunctionMar 14, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT BEFORE OPERATION, THERE WAS NO SIGNAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603801 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A PAROTID OPERATION, THERE WAS A DELAYED CURRENT DELIVERY TONE IN THE NIM 3.0 SYSTEM. THE FOLLOWING STEPS WERE TAKEN: THE MUTING DETECTOR WAS TURNED OFF, THE VOLUME WAS INCREASED, THE THRESHOLD WAS LOWERED, THE PATIENT WAS NOT PARALYZED, THE ELECTRODE CHECK WAS PASSED, THE TAP TEST WAS PASSED, THE PROBE WAS EXCHANGED, THE STIMULATION WAS INCREASED, THE FUSE IN THE PI BOX WAS NOT BLOWN, AND THE ELECTRODES WERE CHANGED. DESPITE THESE STEPS, THE DELIVERY TONE WAS STILL DELAYED. THE SURGERY WAS EXTENDED BY LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561189 ↗
• MalfunctionMar 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO PROCEDURE NIM PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543662 ↗
• 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 THE THERE WAS NO STIMULATION RESPONSE AS STIM 1 WAS NOT WORKING IN THE PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536379 ↗
• MalfunctionMar 5, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS NON RESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525057 ↗
• MalfunctionFeb 26, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING INTRA-OP, THE ELECTRODE WAS NOT SHOWING UP WITH THE PATIENT INTERFACE. IT JUST MAKE NOISE WHEN PLUGGED IN WITH NO SIM ON IT. SWAPPED WITH ANOTHER NIM UNIT AND THE ISSUE WAS RESOLVED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470522 ↗
• MalfunctionFeb 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP, THAT THE DEVICE HAD CHANNEL BLOCKAGE, NO SIGNAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466638 ↗
• MalfunctionFeb 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE DOES NOT SHOW THE STIMULATION RESPONSE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456436 ↗
• MalfunctionJan 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT NIM GENERATOR DOES NOT WORK DURING PATIENT TESTING. NO MORE TRACE AND SPECIFIC SOUND BUT JUST A BEEP WHEN POSITIONING THE NIM IN CONTACT WITH THE NERVES. CHANGE OF NIM DEVICE, INTUBATION TUBE. CHECKING THE CONNECTIONS. PROBLEM STILL EXISTING. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21214888 ↗
• MalfunctionNov 13, 2024Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT PRIOR TO PROCEDURE NIM PATIENT INTERFACE HAD INTERFERENCE. THE PROCEDURE WAS COMPLETED WITH THE BACK UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20671057 ↗
• MalfunctionNov 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593829 ↗
• MalfunctionOct 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20468321 ↗

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-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-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