NIM-Neuro® 8253410 (UDI 00613994499653)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00613994499653), received between Oct 16, 2017 and May 21, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (12 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED STATING NIM SYSTEM FAILED SELF TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244572 ↗
• MalfunctionApr 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, NIM PATIENT INTERFACE HAD NO STIMULATION CURRENT. PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24882307 ↗
• MalfunctionApr 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD NOT WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796553 ↗
• MalfunctionFeb 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP THE NIM 3.0 PATIENT INTERFACE PROVIDED THE NO STIMULATION RESPONSE. THE STIM RETURN ON THE MONITOR SHOW (0) WHEN ATTEMPTING TO DELIVER STIMULUS. THERE WAS NO STIMULUS DELIVERY TONE HEARD AND NO WAVEFORM DISPLAYED, WHEN ATTEMPTING TO STIMULATE THE NERVE THE PROCEDURE WAS COMPLETED WITH ANOTHER EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275209 ↗
• MalfunctionNov 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED THAT ELECTRODES WERE NOT SENSING THE PATIENT INTERFACE. THE PROCEDURE WAS COMPLETED WITHOUT NIM NEURO 3.0.THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642411 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE PATIENT INTERFACE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084990 ↗
• MalfunctionJun 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PREOPERATIVELY WHILE PREPARING FOR MONITORING RECURRENT LARYNGEAL NERVE THE PATIENT INTERFACE BOX HAD NO RESPONSE TO STIMULATION. THRESHOLD SET TO 150 MICROVOLTS. STIM RETURN, LOCATED UNDER THE STIMULUS SETTING ON THE MONITOR SHOWED 0. ADJUSTMENT OF POSITION AND INTUBATION DID NOT RESOLVE THE ISSUE. THERE WAS NO STIMULUS DELIVERY TONE HEARD WHEN ATTEMPTING TO STIMULATE AND NO WAVEFORM DISPLAYED ON MONITOR. ALL THIS WAS TESTED WITH SIMULATOR AND THERE WAS NO SIGNAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294911 ↗
• MalfunctionApr 18, 2025Signal Artifact/Noise; Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Signal Artifact/Noise; Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING PRE-OP, THE NIM 3.0 PATIENT INTERFACE NOT WORKING PROPERLY (FAULTY) AND CANNOT BE USED NORMALLY. THERE WILL BE ABNORMAL INTERFERENCE SIGNALS ON THE MONITORING INTERFACE, AND THE CONNECTION LINE WILL AGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863499 ↗
• MalfunctionMar 10, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRE-OP, DEVICE HAD NO RESPONSE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556880 ↗
• MalfunctionMar 6, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRE-OP, THERE WAS NO RESPONSE WHEN THE PATIENT INTERFACE WAS CONNECTED TO CONSOLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535859 ↗
• MalfunctionFeb 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THE PATIENT INTERFACE SIGNAL WAS NOT DETECTED. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471443 ↗
• MalfunctionAug 23, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT USER CANNOT IDENTIFY THE PLACEMENT OF NEEDLES, AS SUPPOSED TO BE TICK AS CHECK, BUT SHOWING "X". WHEN PROMPTED TO CONTINUE, IT SENSES THE NEEDLE PLACEMENTS IN THE NERVES THRU SOUNDS.THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20051732 ↗
• MalfunctionJun 13, 2024Incorrect, 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 19534428 ↗
• MalfunctionMar 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED STATING NO ERROR CODES DISPLAYED, OR NONE NOTICED AT THE TIME, AND ISSUE WAS NOT RESOLVED BY REPOSITIONING ANY COMPONENTS OF THE NIM SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966881 ↗
• MalfunctionJul 20, 2023Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359331 ↗
• MalfunctionNov 4, 2022Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15728930 ↗
• MalfunctionJul 11, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977516 ↗
• MalfunctionJun 8, 2022Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT DEVICE IS NOT WORKING. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630480 ↗
• MalfunctionFeb 18, 2022Sensing Intermittently; Sensing Intermittently

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DEVICE GAVE AN INTERMITTENT RESPONSE DURING USE / INTRA OP. THERE WAS NO RESPONSE FROM THE PROBE WHEN PLACED ON TISSUE. NORMALLY RUNS AS 0.02-0.04MA ACOUSTIC RESPONSE. THERE WAS NO PATIENT IMPACTED. THERE WAS NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559074 ↗
• MalfunctionDec 14, 2021Break; Break

  THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE NERVE MONITORING INTERFACE WAS BROKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001698 ↗
• MalfunctionAug 12, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  UPON COMPLETION OF THE SERVICE REPORT, IT WAS CONFIRMED THAT THE DEVICE WAS RETURNED FOR PREVENTATIVE MAINTENANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395282 ↗
• MalfunctionAug 11, 2020Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389573 ↗
• MalfunctionAug 6, 2020Failure to Sense; Use of Device Problem; Failure to Sense; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT INTERFACE FUSE WAS CHANGED PRIOR TO USE. THE SURGEON WAS STILL NOT SURE IF THE DEVICE WAS WORKING PROPERLY. THE SURGEON REALISES INTRA-OP IF IT WAS WORKING OR NOT. THE DEVICE WAS NOT RESPONDING LIKE IT SHOULD WHEN YOU STIMULATE THE NERVE AND THE SURGEON IS SURE IT IS THE NERVE. THERE WAS NO ERROR CODE DISPLAYED.

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

  MAUDE report 10376073 ↗
• MalfunctionJul 10, 2020Use of Device Problem; Use of Device Problem

  ON FOLLOW UP IT WAS REPORTED THAT THE EVENT OCCURRED JUST BEFORE THE PROCEDURE AND ANOTHER DEVICE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256918 ↗
• MalfunctionFeb 11, 2020Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT A DEVICE WAS BROKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9693156 ↗

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-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-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