NIM Vital™ NIM4CM01 (UDI 00763000395896)Recalls & reported problems

Summary

The FDA's MAUDE database contains 795 adverse event reports that list this exact device (DI 00763000395896), received between Sep 2, 2022 and Sep 30, 2026 — classified as 11 injuries, 784 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (493 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 18, 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-1223-2022 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 795 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Negative Result; Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947670 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during surgery, the patient interfaces were unable to stimulate and after troubleshooting perform Issue persisted with both PI boxes and unable to replicate any issues with patient simulator. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911261 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776368 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during intra-op, user said they were on nerve however NIM was giving no response and also had loose wire.  There was no known patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50772327 ↗
• MalfunctionSep 11, 2026Inappropriate Audible Prompt/Feedback

  It was reported that during intra op there was excessive noise when using a Bovie. They confirmed they were using the muting clamp. They tried both a wired and wireless connection, which did not resolve. Issue was not present with bovie was not being used. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726770 ↗
• MalfunctionSep 10, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50706762 ↗
• MalfunctionSep 2, 2026Inappropriate Audible Prompt/Feedback

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50558736 ↗
• MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: Insufficient Information

  MAUDE report 50494131 ↗
• MalfunctionAug 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the Console stopped working during a case. Surgeon aware and able to continue case without concern. There was no known patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50468654 ↗
• MalfunctionAug 18, 2026Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295725 ↗
• MalfunctionAug 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that prior to procedure the NIM Console will not interface. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50271334 ↗
• MalfunctionAug 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50142405 ↗
• MalfunctionJul 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50097008 ↗
• MalfunctionJul 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094801 ↗
• MalfunctionJul 31, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094761 ↗
• MalfunctionJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50050440 ↗
• MalfunctionJun 26, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THERE HAS BEEN A LOT OF CONTINUOUS BEEPING WHEN USING THE NIM FOR NECK CASES(PAROTIDS AND THYROIDS). EVEN WITH THE MACHINE PLACED AWAY FROM CAUTERY, PLUGGED INTO DIFFERENT OUTLETS, AND CORDS NEATLY PLACED ON PATIENT, THE NOISE IS QUITE EXCESSIVE. THE USER MADE SURE THAT ALL OF THE PATIENT ELECTRODES WERE PLACED PROPERLY AND NOT TANGLED, PLUGGED THE NIM INTO A SEPARATE OUTLET FROM OTHER EQUIPMENT AND HAD IT PLACED FAR AWAY FROM THE CAUTERY AND OTHER MACHINES. ANESTHESIA ALSO MADE SURE THE ENDOTRACHEAL TUBE WAS PLACED PROPERLY. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633443 ↗
• MalfunctionJun 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SYSTEM DISPLAYED A PATIENT INTERFACE, FAULT DETECTED MESSAGE. THE ISSUE PERSISTED EVEN AFTER REBOOTS. THE DEVICE COULD NOT BE USED FOR SURGERY AND THE SITE POTENTIALLY ENDED CANCELLING THE SURGERY. THE USER ADMITTED TO HAVE DROPPED THIS REMOTE A COUPLE TIMES IN THE PAST. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25427395 ↗
• MalfunctionJun 3, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT PRE OP THE DEVICE WAS BEEPING AND MAKING A BUNCH OF NOISE WHEN THE PI BOX IS PLUGGED IN TO THE CONSOLE. TRIED 3 OTHER PI BOXES, AND 2 MADE THE NOISES. THE SYSTEM DISPLAYS AN OUT OF MEASUREMENT RANGE MESSAGE WITHOUT EXCESSIVE NOISE. TROUBLESHOOTING DONE BY SITE: SWAPPED BETWEEN WIRED/WIRELESS CONNECTION, SWAPPED PI BOXES, COMPLAINT NOT RESOLVED, SWAPPED CONSOLE, COMPLAINT NOT REPLICATED, CONFIRMED SYSTEM IS IN ITS OWN ISOLATED OUTLET. TROUBLESHOOTING BY REP: REPLICATED ISSUE WITH HER OWN PI BOX, REPLICATED WITH SITE'S PI BOXES, CONFIRMED NO OTHER CONSOLE IS EXPERIENCING THIS ISSUE THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25370847 ↗
• MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP ,THE PATIENT INTERFACE BOX DISPLAYING A FAULT MESSAGE DURING A WIRED CONNECTION. TROUBLESHOOTING WAS PERFORMED BY POWER CYCLING THE PATIENT INTERFACE BOX, REBOOTING THE PATIENT INTERFACE AND SWITCHING TO A WIRELESS CONNECTION ; BUT ISSUE STILL PERISITED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25274359 ↗
• MalfunctionMay 25, 2026Computer Software Problem; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT WHEN UNPLUGGING THE CONSOLE FROM WALLPOWER, A "BATTERY NOT AVAILABLE" MESSAGE DISPLAYS, THEN THE SYSTEM SHUTS DOWN. THE BATTERY WAS RESEATED AND THE UNPLUGGING WAS AGAIN ATTEMPTED TO REPLICATE THE ISSUE BUT THE ISSUE COULD NOT BE REPLICATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273302 ↗
• MalfunctionMay 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE INTERFACES WERE NOT CONNECTING VIA WIRELESS OR WIRED CONNECTION. ALSO, MUTING ERROR WAS GIVEN. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25272347 ↗
• MalfunctionMay 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT NIM PATIENT INTERFACE WAS UNABLE TO CONNECT VIA WIRELESS AND WIRED CONNECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25269052 ↗
• MalfunctionMay 20, 2026Wireless Communication Problem

  IT WAS REPORTED THAT THE WIRELESS CONNECTION IS INTERMITTENT ON BOTH PI BOXES. AFTER TESTING, USER BELIEVES THE ISSUE MAY BE FOLLOWING THE LEFT DOCKING PORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226251 ↗
• MalfunctionMay 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED, THE ISSUE WAS ONLY SELF TEST FAILURE AND SINCE THE DEVICE FAILED TO PASS THE SELF TEST, COULDN'T CONTINUE TO THE CHECK ELECTRODE AND MONITORING SCREENS OF THE DEVICE. TRIED TO SHUT DOWN THE SYSTEM A FEW TIMES AND TO START IT AGAIN AND THE SELF NOTICE CONTINUED. THE CUSTOMER USED ANOTHER NIM VITAL DEVICE THEY HAVE IN THE HOSPITAL AND THEY MANAGED TO OPERATE WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226187 ↗

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-1224-2022 · May 3, 2022 · Open, Classified
  NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2