NIM Vital NIM4CPB1Recalls & reported problems
Medtronic Xomed, Inc. · PATIENT INTERFACE NIM4CPB1 NIM 4.0 · Class 2
All models of NIM Vital (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This NIM Vital nerve monitoring patient interface connects to a system that tracks nerve signals during surgery. Its 214 reports include no injuries and no deaths. Most describe incorrect or unclear readings from the monitor, and some describe error messages or connection problems. There are 2 open recalls, over extra signal interference that can delay procedures and possible false negative readings.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 208
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00763000528584), received between Oct 18, 2023 and Sep 29, 2026 — classified as 208 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (183 reports).
2 FDA recall records name this device's identifier, 2 still open.
2 other recalls 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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 ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings183
- Inappropriate Audible Prompt/Feedback13
- Incomplete or Inadequate Connection11
- False Negative Result9
- Problem with Software Installation7
- Application Program Freezes or Fails to Launch5
- Battery Problem4
- Connection Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions193
- Insufficient Information23
Recent adverse event reports
The 25 most recent of 208 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: Insufficient Information
MAUDE report 50933296 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50707400 ↗MalfunctionAug 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50400797 ↗MalfunctionJul 6, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE NIM PI WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25713379 ↗MalfunctionJun 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE NIM PATIENT INTERFACE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25426894 ↗MalfunctionJun 4, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE NIM VITAL MONITOR, THE STIMULATION OUTPUTS ON THE PATIENT INTERFACE MODULE ARE DEFECTIVE AND CABLE ISSUE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25392169 ↗MalfunctionJun 1, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT INTRA-OP, THE ISSUE WITH THE NIM VITAL CONSOLE AND REMOTE (ECN: SHP36130) WHERE THE REMOTE FAILED TO DETECT THE #2 RED PORT AND REMAINING PORTS WERE WORKED. THE CONNECTION ISSUE WAS RESOLVED BY SWITCHING TO A DIFFERENT REMOTE; HOWEVER, DURING USE, THE CONSOLE BEGAN FUNCTIONING INTERMITTENTLY AND EMITTING MULTIPLE ALERT SOUNDS. THE CONSOLE WORKING WELL WITH OTHER PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25353321 ↗MalfunctionMay 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE, THE PROBLEM IS THAT THE EQUIPMENT DOES NOT CONNECT WITH THE INTERFACE, PREVENTING IT FROM WORKING PROPERLY. BOTH, WIRED AND WIRELESS WAS ATTEMPTED AND BOTH FAIL. AFTER THE CHECKS CARRIED OUT, THE FAILURE SEEMS TO BE RELATED TO THE INTERFACE ITSELF. THE CONSOLE WORKED FINE. THE PROCEDURE WAS COMPLETED WITH OTHER EQUIPMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329109 ↗MalfunctionMay 22, 2026Connection Problem
IT WAS REPORTED THAT NIM PATIENT INTERFACE PLUG CONNECTION WAS NOT WORKING. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 25258942 ↗MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE PATIENT INTERFACE SHOWS THE ERROR "ERROR IN THE PATIENT INTERFACE" ON THE CONSOLE. WITH A DIFFERENT PATIENT INTERFACE, THE ABSENCE IS NOT SHOWN. AFTER THE PATIENT INTERFACE WAS REMOVED FROM THE CONSOLE, IT DID CONNECT AND THE BOX AROUND THE MESSAGE TURNED GREEN, HOWEVER, THE MESSAGE "ERROR DETECTED IN THE PATIENT INTERFACE, "PATIENT INTERFACE FAULT DETECTED". IF THE PROBLEM PERSISTS, PLEASE CONTACT TECHNICAL SUPPORT" APPEARED. THE CONSOLE WORKED PERFECTLY WITH A DIFFERENT PATIENT INTERFACE. THE PROCEDURE WAS COMPLETED BY REPLACING THE NIM PATIENT INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237834 ↗MalfunctionMay 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, NIM SYSTEM WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179814 ↗MalfunctionMay 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING SETUP, THE NIM PATIENT INTERFACE DISPLAYED "PI FAULT DETECTED" ERROR MESSAGE MULTIPLE TIMES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167754 ↗MalfunctionMay 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING SET UP, PI BOX PROBE PORT IT DOES NOT MAKE ANY SOUNDS. TRIED SAME PROBE ON OTHER PI'S AND PROBE WORKS FINE THERE WAS NO PATIENT INVOLVED.
Patient problems: Insufficient Information
MAUDE report 25167580 ↗MalfunctionMay 6, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE OP, DEVICE POSSESSED PATIENT INTERFACE FAULT DETECTED ERROR. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25091950 ↗MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT, THE NIM VITAL SYSTEM WAS SHOWING "FAULT DETECT ERROR MESSAGE". THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25064639 ↗MalfunctionApr 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
ADDITIONAL INFORMATION RECEIVED EVENT OCCURRED DURING PRE-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25033016 ↗MalfunctionApr 27, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PATIENT INTERFACE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001301 ↗MalfunctionApr 27, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT, THE STIM ONE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994399 ↗MalfunctionApr 27, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE CONSOLE IS DISPLAYING A PATIENT INTERFACE FAULT MESSAGE WHEN ATTEMPTING TO CONNECT THE INTERFACE TO THE CONSOLE. TROUBLESHOOTING DONE, TRIED BOTH WIRED AND WIRELESS CONNECTION - FAULT STILL APPEARS. TESTED WITH ANOTHER PI - FAULT MESSAGE DOES NOT APPEAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994292 ↗MalfunctionApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE NIM PI HAD CABLE ISSUE, THE DEVICE WAS NOT CONNECTING IN WIRED/WIRELESS MODE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987105 ↗MalfunctionApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO PROCEDURE THE NIM CONSOLE DISPLAYED THE PATIENT INTERFACE FAULT ERROR WHEN TRYING CONNECT WITH THE PATIENT INTERFACE. THE DEVICE COULDN'T BE USED BECAUSE THE INSTALLATION COULDN'T BE COMPLETED. THE ERROR DID NOT OCCUR WHEN ANOTHER PATIENT INTERFACE WAS CONNECTED WITH THE SAME NIM CONSOLE. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24975871 ↗MalfunctionApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE, THE NERVE MONITOR WAS PLAYING UP DURING A MAJOR EAR CASE AND THEY COULD NOT GET ANY CONNECTION AT ALL. AFTER THE PROCEDURE USER CONNECTED THE DEVICE TO THE TEST MODULE AND THE CONNECTION WAS FINE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24975803 ↗MalfunctionApr 22, 2026False Negative Result
IT WAS REPORTED THAT DEVICE WOULD INTERMITTENTLY WOULD NOT RECORD RESPONSES DURING SURGERY. USER PERFORMED ELECTRODE CHECK - ALL CHANNELS PASSING. USER CHECKED FUSES AND FOUND NO ISSUES. USER RESEATED ELECTRODES ON PATIENT INTERFACE- ISSUE STILL PRESENT AFTERWARD. SITE ADJUSTED THRESHOLD AND STIM OUTPUT - ISSUE STILL PRESENT. SITE SWAPPED OUT STIMULATOR PROBE - ISSUE STILL PRESENT. SITE SWAPPED OUT PATIENT INTERFACE - ISSUE RESOLVED. USER CHECKED CONSOLE AND PATIENT INTERFACE WITH PATIENT SIMULATOR AFTER THE CASE AND COULD NOT REPLICATE THE ISSUE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949931 ↗MalfunctionApr 20, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE PATIENT INTERFACE UNIT OF THE NIMVITAL WAS DEFECTIVE AND PLUG DAMAGED OR HAD NON SPECIFIC DAMAGE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926445 ↗MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT INTRA OPERATIVELY, THE FUSE GAVE AN ALARM AND DISPLAYED ERROR MESSAGE "PATIENT INTERFACE FUSE FAULT DETECTED, CHECK THE PATIENT INTERFACE FUSES" AFTER ENTERING THE MONITORING SCREEN". THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24906874 ↗
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, ClassifiedNIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
- Z-1224-2022 · May 3, 2022 · Open, ClassifiedNIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Other Stimulator, electrical, evoked response devices
- NIM Vital™ NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls795 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls331 reports
- POWEREASE™ Instruments 2300000Medtronic Sofamor Danek, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE1 recall203 reports
- NIM Vital™ NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls47 reports
- NIM-Response® 8253200Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE113 reports
- NA DAQ916Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE80 reports
- Neuromaster G1 DC-200BNihon Kohden Corporation · STIMULATOR, ELECTRICAL, EVOKED RESPONSE73 reports
- NA EEX901Medtronic Xomed, Inc. · STIMULATOR, ELECTRICAL, EVOKED RESPONSE66 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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