NIM VitalRecalls & reported problems across all models
Medtronic Xomed, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one NIM Vital model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,696
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 4
We found 9 models of NIM Vital by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 1,696 adverse event reports in the FDA's MAUDE database, received between Sep 2, 2022 and Sep 30, 2026 — classified as 22 injuries, 1,674 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,196 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
NIM Vital recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 10, 2025Open, 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 · names 8 of these models · Recall details · FDA record ↗
- Jun 24, 2024Open, Classified
Potential for false negative response on the NIM Vital Nerve Monitoring System
Z-2409-2024 · Root cause: Under Investigation by firm · names 8 of these models · Recall details · FDA record ↗
- May 3, 2022Open, Classified
Software anomaly was identified.
Z-1224-2022 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗
- May 3, 2022Open, Classified
Software anomaly was identified.
Z-1223-2022 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗
Most reported NIM Vital problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1,196
- Inappropriate Audible Prompt/Feedback221
- False Negative Result181
- Failure to Power Up114
- Computer Software Problem86
- False Positive Result80
- Application Program Freezes or Fails to Launch50
- Problem with Software Installation47
Patient problems
- No Clinical Signs, Symptoms or Conditions1,594
- Insufficient Information113
- Nerve Damage13
- Electric Shock4
- Paralysis4
- Facial Paralysis2
- Unintended Extubation2
- Hemorrhage/Blood Loss/Bleeding1
NIM Vital models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NIM Vital™ NIM4CM01STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls795 reports
- NIM Vital™ NIM4CPB1STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls331 reports
- NIM Vital NIM4CM01STIMULATOR, NERVE2 recalls260 reports
- NIM Vital NIM4CPB1Stimulator, electrical, evoked response2 recalls208 reports
- NIM Vital™ NIM4CM01STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 recalls47 reports
- NIM Vital™ NIM4CPB1STIMULATOR, NERVE3 recalls45 reports
- NIM Vital NIM4CM01RFSTIMULATOR, NERVE2 recalls8 reports
- NIM Vital NIM4CPB1RFSTIMULATOR, NERVE2 recalls1 report
- NIM Vital™ NIM4CPB2STIMULATOR, NERVE1 report
Recent NIM Vital adverse event reports
The 15 most recent reports across all models, 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 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: Insufficient Information
MAUDE report 50933296 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the system's PI box "intermittently functions." There is no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931068 ↗MalfunctionSep 29, 2026False Negative Result
It was reported that intra-op, the NIM Vital was giving an audible alarm approximately every minute with no corresponding alarm message displayed on screen. All connections were confirmed correct. The stimulation delivery tone was absent, although visual stimulation feedback was displayed under the stimulation current and muscle twitch was observed. No passive EMG activity was detected with Event Capture turned off, and no nerve response was observed when stimulating the RLN. Changing patient interfaces, using hard wire connections and rebooting the unit (unplugged for 30 seconds) did not resolve the issue. Adjusting the volume reportedly restored operation however, due to the abnormal behavior, Medtronic recommended that the unit be assessed by a service engineer. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928090 ↗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 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that intra-op, the NIM Console had not stimulation properly, switched from brief tone to continuous, at first there was no stimulation response but when probe was removed and put back on the nerve it gave an overwhelming response. No patient impact or injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877735 ↗MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that, the no nerve stimulation from the NIM Console. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868017 ↗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, 2026Computer Software Problem; False Negative Result; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733110 ↗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, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50707400 ↗MalfunctionSep 10, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50706762 ↗MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch
It was reported that both PI boxes displayed the message "PI Box Faulted." Issue persisted with reboots. Confirmed that the system was plugged into an isolated outlet. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50661783 ↗MalfunctionSep 2, 2026Inappropriate Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558736 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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