NIM Vital™ NIM4CPB1 (UDI 00763000395902)Recalls & reported problems

Summary

The FDA's MAUDE database contains 331 adverse event reports that list this exact device (DI 00763000395902), received between Sep 12, 2022 and Aug 24, 2026 — classified as 331 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (281 reports).

3 FDA recall records name this device's identifier, 3 still open.

1 other recall cover devices cleared under the same FDA submission (K200759); 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 16, 2026.

Recalls naming this device

1. Mar 10, 2025Class IIOpen, Classified

   Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

   Z-1623-2025 · Root cause: Software change control · Recall details · FDA record ↗

2. Jun 24, 2024Class IOpen, Classified

   Potential for false negative response on the NIM Vital Nerve Monitoring System

   Z-2409-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 3, 2022Class IIOpen, Classified

   Software anomaly was identified.

   Z-1224-2022 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 331 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50407086 ↗
• MalfunctionJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50050219 ↗
• MalfunctionJun 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIM PATIENT INTERFACE HAD AN ALLEGED DEFECT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663113 ↗
• MalfunctionJun 15, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP, IT WAS FOUND THAT THE DEVICE GENERATES ABNORMAL ECG SIGNALS I.E.ARRHYTHMIA AND ECTOPIC SIGNALS ON THE PATIENT MONITOR WHEN THEY STARTED NERVE MONITORING. THE PATIENT INTERFACE WAS SWAPPED WITH A SPARE ONE, AFTER WHICH NO IRREGULARITIES WERE OBSERVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499371 ↗
• MalfunctionJun 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIM SYSTEM HAD A FAILURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394808 ↗
• MalfunctionJun 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Temperature Problem

  IT WAS REPORTED THAT, THE NIM PATIENT INTERFACE WAS SHOWING "PATIENT INTERFACE FAULT DETECTED". THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25387177 ↗
• MalfunctionJun 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT INTERFACES HAD ALLEGED MALFUNCTION. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25365158 ↗
• MalfunctionMay 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT INTERFACE GIVES PI FAULT DETECTED ERROR. THEY ATTEMPTED BOTH WIRED AND WIRELESS WITH NO RESOLUTION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255632 ↗
• MalfunctionMay 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, AT THE START OF AN IN SERVICE, THE NIM PI WAS NOT WORKING, DID NOT RESPOND TO STIM, THE NIM CONSOLE INVOLVED IN THE EVENT WAS WORKING FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25251973 ↗
• MalfunctionMay 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT INTERFACE HAS FAULT DETECTED ERROR. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25226240 ↗
• MalfunctionMay 20, 2026Battery Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE NIM PI WAS NOT CONNECTING IN WIRED AND WIRELESS MODE. THE DEVICE WAS NOT CHARGING EITHER. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25226037 ↗
• MalfunctionMay 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT NIM STARTS UP NORMALLY AND SOMETIMES IT DOESN'T PASS THE SELF-TEST OR IT SHOWS PATIENT INTERFACE FAILURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197209 ↗
• MalfunctionMay 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT NIM VITAL HAD PATIENT INTERFACE FAULT DETECTED ERROR MESSAGE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25195030 ↗
• MalfunctionMay 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: Insufficient Information

  MAUDE report 25120507 ↗
• MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE OP, DEVICE HAD CONNECTION ISSUE. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071707 ↗
• MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE MODULE DISCONNECT (GOES OUT IN BOTH MODES WIRED/WIRELESS) WHILE IN USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25065433 ↗
• MalfunctionApr 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE NIM SYSTEM CAUSES THE FOLLOWING ALARM; "THE QUALITY OF THE PATIENT INTERFACE'S WIRELESS CONNECTION IS POOR OR ANOTHER DEVICE IS INTERFERING WITH ITS CONNECTION. CONNECT THE PATIENT INTERFACE CABLE". WHEN THIS ALARM IS ACKNOWLEDGED, IT IS REPEATED A FEW SECONDS LATER, WHETHER THE INTERFACE IS PHYSICALLY CONNECTED TO THE CONSOLE OR NOT. THE ASSOCIATED CONSOLE HAS BEEN TESTED WITH A DIFFERENT INTERFACE UNIT AND THE ERROR RECURS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24995946 ↗
• MalfunctionApr 27, 2026False Negative Result

  IT WAS REPORTED THAT THE PATIENT INTERFACE WAS NOT BEING RECOGNIZED BY THE SYSTEM. IT WAS NOT STIMULATING AT ALL. CONSOLE HAS NO ISSUE AS IT WORKED WITH ANOTHER PI BOX. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24994126 ↗
• MalfunctionApr 21, 2026False Negative Result

  IT WAS REPORTED THAT PRE-OP, THE PATIENT INTERFACE WAS NOT BEING RECOGNIZED BY THE SYSTEM. THE UNIT WAS WORKING INITIALLY, THEN IT WAS NOT STIMULATING AT ALL. SURGEON WAS USING A PRASS PROBE TO STIMULATE THE NERVE AND NOTHING WAS PICKED UP. CHANGED THE PRASS PROBE. PROBLEM CONTINUED. CHANGED TO THE OTHER BOX ON THE CONSOLE. IT THEN WORKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939288 ↗
• MalfunctionApr 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE DEVICE CHECKOUT; SYSTEM DISPLAYS AN ERROR INDICATING THE PATIENT INTERFACE IS NOT WORKING AND THE ERROR WAS PATIENT INTERFACE FAULT DETECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938252 ↗
• MalfunctionApr 21, 2026Loose or Intermittent Connection; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE NIM VITAL SYSTEM INTERMITTENT CONNECTIVITY ISSUE WITH WIRE AND WIRELESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935795 ↗
• MalfunctionApr 19, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING INTRA-OP, THE NIM VITAL PATIENT INTERFACE HAD NO STIMULATION AND SHOWING CONTINUOUS STIMULATION NOISE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PATIENT INTERFACE. NIM VITAL CONSOLE WORKING FINE WITH OTHER PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921058 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET UP DEVICE WAS GETTING PATIENT INTERFACE FAULT DETECTED. ANOTHER PATIENT INTERFACE WAS USED AND IT WORKED CORRECTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906869 ↗
• MalfunctionApr 16, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING USE, STIM1 HAD CHANNEL ISSUE. THE CONNECTION FAIL GRADUALLY CAUSING INTERFERENCES AND MISFUNCTION. USER COMPLETE THE PROCEDURE WITH OTHER INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894796 ↗
• MalfunctionApr 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Problem with Software Installation

  ADDITIONAL INFORMATION RECEIVED THAT THE CONSOLE WAS WORKING FINE WITH OTHER PATIENT INTERFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867579 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200759. One submission often covers many models, so check the product and lot details in each record.

• Z-1223-2022 · May 3, 2022 · Open, Classified
  NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2