NIM-Neuro® 8253401 (UDI 00643169230408)Recalls & reported problems
Medtronic Xomed, Inc. · MAINFRAME 8253401 NIM NEURO 3.0 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 00643169230408), received between Dec 8, 2025 and Dec 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Reports received per month
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 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT MAINFRAME WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741500 ↗
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-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-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-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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- 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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