NIM-Response® 8253210Recalls & reported problems
Medtronic Xomed, Inc. · PATIENT INTERFACE 8253210 NIM PULSE 3.0 · Class 2
All models of NIM-Response (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994499639), received between Mar 17, 2020 and Jun 10, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2021Use of Device Problem; Use of Device Problem
ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE INTERFACE FAILED BECAUSE IT FELL ON THE FLOOR BEFORE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11974302 ↗MalfunctionMar 17, 2020Use of Device Problem; Use of Device Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE INTERFACE WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9841706 ↗
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-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
- 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
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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