Nerve Integrity Monitor (NIM) 3.0 8253200RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169782501), received between Nov 27, 2017 and Mar 6, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE DEVICE HAD NO COMMUNICATION. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536705 ↗
• MalfunctionMay 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIM PATIENT INTERFACE WAS MALFUNCTIONING. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246439 ↗
• MalfunctionNov 14, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE HAD NOT WORKING. PATIENT INTERFACE EMG TEST STAYS WITH QUESTION'S MARKS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130279 ↗
• MalfunctionJun 5, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING INTRA-OP, THE DEVICE WAS NOT STIMULATING. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064827 ↗
• MalfunctionDec 28, 2022Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT DEVICE CHANNEL 1 PORT IS INTERMITTENT. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061802 ↗
• MalfunctionMay 18, 2022Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14430102 ↗
• MalfunctionDec 8, 2020Use of Device Problem; Use of Device Problem

  ON FOLLOW-UP, IT WAS REPORTED THAT THE FACILITY HAVE 2 UNITS AND THEY JUST SWAPPED THEM BEFORE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10967573 ↗
• MalfunctionOct 14, 2020Sensing Intermittently; Failure to Sense; Device Sensing Problem; Sensing Intermittently; Failure to Sense; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE STIMULUS PROBE DID NOT IMMEDIATELY RESPOND. THE STIMULUS WAS TRIGGERED AGAIN AND IT ACTIVATED. THERE WAS MOMENTARY DELAY (LESS THAN 1 HOUR).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10676350 ↗
• MalfunctionApr 9, 2020Intermittent Continuity; Intermittent Continuity

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT INTERFACE WAS WORKING INTERMITTENTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9942161 ↗
• MalfunctionOct 8, 2019Device Sensing Problem; Device Sensing Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS NOT SENSING STIMULATION. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9166964 ↗
• MalfunctionJun 17, 2019Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT INTERFACE WAS NOT FUNCTIONING. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8703345 ↗
• MalfunctionMar 5, 2019Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER REPORTED THAT THE INTERFACE WAS NOT FUNCTIONING. THERE WERE NO PATIENT ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8391382 ↗
• MalfunctionFeb 25, 2019Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PATIENT INTERFACE WAS NOT WORKING. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367453 ↗
• MalfunctionNov 19, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8086134 ↗
• MalfunctionNov 9, 2018Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT THE NERVE MONITOR WAS NOT GETTING ANY STIMULUS, NO STIMULATION RESPONSE OR NOT GETTING ANY POSITIVE/NEGATIVE SIGNALS FROM THE UNIT. THE PATIENT INTERFACE WAS STILL NOT WORKING WHICH JUST CAME FROM REPAIR. THE CASE WAS COMPLETED USING ANOTHER DEVICE. THE CONSOLE WAS WORKING FINE. THEY TESTED THE INTERFACE AND GOT NOTHING ON THE MONITOR (NO STIMULUS SOUNDS OR SIGNALS). THEY SWITCHED THE INTERFACE WITH A LOANER INTERFACE AND IT SEEMED TO OPERATE FINE. THE CONSOLE PASSED ALL SAFE TEST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8055807 ↗
• MalfunctionJun 1, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT THE DEVICE WAS WORKING INTERMITTENTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7561975 ↗
• MalfunctionFeb 13, 2018Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THAT THE NIM SYSTEM WAS INTERMITTENTLY NOT WORKING. THE CASE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO PATIENT IMPACT. THIS IS REGULATORY REPORT 2 OF 2 (PATIENT INTERFACE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266040 ↗
• MalfunctionNov 27, 2017Electrical Shorting; Electrical Shorting

  THE CUSTOMER REPORTED THEY WERE UNABLE TO DO ANY NERVE STIMULATION OR RECEIVE NERVE FEEDBACK INTRAOPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062382 ↗

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