NIM Vital NIM4CPB1RFRecalls & reported problems
Medtronic Xomed, Inc. · PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB · Class 2
All models of NIM Vital (9)
Data updated Oct 18, 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.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000003005), received between Dec 26, 2025 and Dec 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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 18, 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 Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT INTRA-OP, THERE WAS PATIENT INTERFACE FAULT DETECTED MESSAGE AND WOULD NOT STOP OR GO AWAY. THE MESSAGE KEPT DI SPLAYING. THE CONSOLE WORKED FINE WITH ANOTHER PI BOX AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894746 ↗
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, NERVE devices
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 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 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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