NIM-Neuro® 8253410 (UDI 00643169283299)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169283299), received between Nov 30, 2018 and Jul 28, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50050619 ↗
• MalfunctionJan 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THYROIDECTOMY SURGERY, THERE WAS NO PROPER TRANSMISSION OF THE ELECTRICAL SIGNAL. THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCT. THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING AT THE TIME OF THE EVENT. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127937 ↗
• MalfunctionNov 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT INTERFACE UNIT'S CONNECTION TO THE MONITOR IS BROKEN, AS WELL AS TO THE ELECTRODE FITTINGS, WHICH MAKE POOR CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602933 ↗
• MalfunctionJun 9, 2025Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE, THE NIM 3.0 PATIENT INTERFACE WAS INTERMITTENTLY NOT WORKING WHEN THE PROBE WAS ATTACHED TO THE STIM 1 PORT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166563 ↗
• MalfunctionOct 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Fitting Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fitting Problem

  THE ELECTRODE KEPT LOSING CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490416 ↗
• MalfunctionSep 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202434 ↗
• MalfunctionNov 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS NOT FUNCTIONING AS IT SHOULD .NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18197586 ↗
• MalfunctionNov 9, 2022Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROVIDER(HCP) REPORTED THAT THE DEVICE DOES NOT WORK. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757561 ↗
• MalfunctionMay 31, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE DOES NOT REGISTER ELECTRODES, VOCAL. THE DEVICE HAD INCONSISTENT READING. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545643 ↗
• InjuryOct 9, 2020Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED THAT MAINFRAME STATED THAT THE EVENT THAT OCCURRED DURING A PROCEDURE FOR LEFT SIDED CHOLESTEATOMA REMOVAL: WHERE IN A NURSE WAS ASSIGNED TO THE CASE DECREASED THE VOLUME OF THE NIM TO THE MINIMUM OF 5% DUE TO EXCESS NOISE WITHOUT CONSULTING OR ADVISING THE SURGEON. DURING THE MASTOIDECTOMY, THE SURGEON EXPOSED THE LEFT FACIAL NERVE AND TRIED TO STIMULATE THE NERVE BUT HEARD NO RESPONSE. THE SURGEON ASKED THE NURSE IF EVERYTHING WAS ALRIGHT WITH THE NIM. THE NURSE INFORMED THE SURGEON THAT THE VOLUME WAS TURNED DOWN AT THE BEGINNING OF THE PROCEDURE. SHE THEN TURNED THE VOLUME UP TO 50%; AFTER WHICH THE NERVE DID NOT RESPOND AND THEY CONCLUDED THAT NERVE INTEGRITY WAS COMPROMISED. THE SURGEON THOUGHT THAT NIM'S VOLUME WAS ON DURING ALL THE PROCEDURE. SINCE THE VOLUME WAS DECREASED TO 5% FOR THE MAJORITY OF THE APPROACH TO THE FACIAL NERVE, IT CAN BE ASSUMED THAT THE SURGEON DAMAGED THE NERVE DURING THAT TIME. THE PATIENT CURRENTLY HAS UNRESOLVED SEVERE LEFT-SIDED FACIAL PARALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10654630 ↗
• MalfunctionAug 13, 2020Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE INTERFACE WAS NON-SPECIFIC DAMAGED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10400251 ↗
• MalfunctionMay 22, 2019Failure to Sense; Failure to Sense

  ON FOLLOW UP, IT WAS STATED THAT THERE WAS NO SIGNAL RESPONSE AND THE ISSUE WAS FOUND DURING TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 8634280 ↗
• MalfunctionNov 30, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE INTERFACE WOULD NOT RECOGNIZE THE ELECTRODES. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8119418 ↗

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-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-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