NIM-Neuro® 8253401 (UDI 00643169782556)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169782556), received between Sep 13, 2022 and May 20, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Failure of Device to Self-Test; Unexpected Shutdown; Failure of Device to Self-Test; Unexpected Shutdown

  IT WAS REPORTED THAT DURING TESTING, THE NIM 3.0 TURNS OFF BY ITSELF / FAILED SELF-TEST. THERE WAS NO PATENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049876 ↗
• MalfunctionMar 5, 2025False Negative Result; Inappropriate Audible Prompt/Feedback; False Negative Result; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT WHILE THE SURGEON HELD THE PROBE ON THE TISSUE, MAINFRAME WAS UNABLE TO PROVIDE THE RESPONSE AND WAS NOISY. NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525482 ↗
• MalfunctionFeb 20, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT PREOP, DEVICE PRODUCED CONSTANT FEEDBACK AND NOISE AS SOON AS IT IS TURNED ON. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418588 ↗
• MalfunctionDec 3, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PRE-OP, NIM SYSTEM WAS UNABLE TO CLEAR A BOOT LOADER SCREEN. ISSUE PERSISTS AFTER SEVERAL REBOOTS. THE MEDTRONIC SPLASH SCREEN NEVER APPEARS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831069 ↗
• MalfunctionNov 13, 2024Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE MAINFRAME DISPLAYS A FATAL ERROR MESSAGE UPON BOOTUP. THE SCREEN DISPLAYS MULTIPLE LINES OF ERROR CODES, ONE OF WHICH SAYS "CANNOT FIND REQUIRED MAP NAME, PRESS ESC TO SKIP BOOTUP" ISSUE PERSISTS AFTER REBOOTS. THE SYSTEM WAS ALSO NOT BOOTING UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20671827 ↗
• MalfunctionOct 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE OP, SYSTEM IS TURNING ON AND OFF RANDOMLY AND TRY'S TO REBOOT AND REPEATS THE PROCESS. NO IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382033 ↗
• MalfunctionAug 6, 2024Computer Software Problem; Failure to Power Up; Computer Software Problem; Failure to Power Up

  IT WAS REPORTED THAT PRE-OP, THE NIM 3.0 SYSTEM WILL NOT BOOT-UP AT ALL, WHITE SCREEN ONLY. THE WHITE SCREEN ISSUE WAS HAPPENING BEFORE THE PROCEDURE. REBOOTED MULTIPLE TIMES AND THE MACHINE WAS FINALLY ABLE TO BOOT. NO ISSUES DURING THE CASE. POST-OP THE MACHINE WAS NOT ABLE TO BOOT AGAIN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920390 ↗
• MalfunctionApr 16, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT SYSTEM IS NOT OUTPUTTING ANYTHING. WHEN THEY USE THE SIMULATOR IT DOES NOT RESPOND. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114962 ↗
• MalfunctionSep 18, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE HAD NO NERVE REACTION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764315 ↗
• MalfunctionApr 19, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT NOISE FROM THE NIM DURING A THYROID PROCEDURE TODAY. RESEATED ELECTRODES IN THE PI BOX AND MOVED THE CONSOLE AWAY FROM THE ANESTHESIA MACHINE. CONFIRMED THAT NO OTHER EQUIPMENT WAS NEARBY THE SYSTEM, IT WAS PLUGGED INTO A DEDICATED WALL OUTLET, AND THERE WAS NO MECHANICAL STRESS ON THE PI BOX OR ELECTRODES. ADJUSTED THE THRESHOLD FROM 100 TO 150 WITH NO CHANGE. THE SURGEON OPTED NOT TO ATTEMPT TO ADJUST THE TRIVANTAGE TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770856 ↗
• InjurySep 13, 2022Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING THYROIDECTOMY PROCEDURE, THE DEVICE DID NOT GIVE AUDIBLE NOTIFICATION WHEN SURGEON STIMULATED TISSUE IN THE SURGICAL FIELD. PROCEDURE BECAME COMPLICATED AS THE RIGHT LARYNGEAL NERVE WAS INJURED.

  Patient problems: Nerve Damage

  MAUDE report 15410303 ↗

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