NIM-Neuro® 8253401 (UDI 00643169547070)Recalls & reported problems
Medtronic Xomed, Inc. · MAINFRAME 8253401 NIM NEURO 3.0 EL ROHS · Class 2
All models of NIM-Neuro (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169547070), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Sensing Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K083124); 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.
Most reported problems
Device problems
- Device Sensing Problem1
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.
MalfunctionJul 28, 2022Device Sensing Problem; Device Sensing Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE STOPPED TRACKING THE TUBE ELECTRODES DURING THE CASE. THERE WAS NO REPORT OF PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AND INDICATED THAT COULD NOT GET CHANNEL TWO TO RESPOND AT THE TIME. DEVICE STARTED TO WORK AFTER SWAPPING OUT THE MAIN SYSTEM. THE EVENT OCCURRED BETWEEN THYROIDECTOMY PROCEDURE. THERE WAS ELECTROSURGICAL EQUIPMENT IN USE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15123368 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083124. One submission often covers many models, so check the product and lot details in each record.
- Z-2342-2012 · Sep 27, 2010 · TerminatedInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient
- Z-2343-2012 · Sep 27, 2010 · TerminatedInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patie
- Z-2344-2012 · Sep 27, 2010 · TerminatedInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patie
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- 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
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
- 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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