NIM-Pulse® 8253202 (UDI 00613994529060)Recalls & reported problems

Medtronic Xomed, Inc. · MAINFRAME 8253202 NIM PULSE 3.0 INTL · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994529060), received between Nov 26, 2019 and Nov 12, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Use of Device Problem3
Incorrect, Inadequate or Imprecise Result or Readings2

Patient problems

No Clinical Signs, Symptoms or Conditions3
No Consequences Or Impact To Patient2

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ADDITIONAL INFORMATION RECEIVED THAT THERE WAS A CONNECTION ISSUE DUE TO USER DID NOT CONNECT THE DEVICES PROPERLY, LATER IT WAS RESOLVED DURING THE EVENT AND CASE COMPLETED SUCCESSFULLY WITH SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539395 ↗
MalfunctionSep 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AN INTERMITTENT WAY OF WORK FOR THE MAINFRAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20123000 ↗
MalfunctionJun 14, 2021Use of Device Problem; Use of Device Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE MAINFRAME WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11991903 ↗
MalfunctionMar 17, 2020Use of Device Problem; Use of Device Problem
A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE MAINFRAME WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9841168 ↗
MalfunctionNov 26, 2019Use of Device Problem; Use of Device Problem
A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9376118 ↗

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 · Terminated
Interfaces 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 · Terminated
Interfaces 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 · Terminated
Interfaces 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

Device details

UDI-DI	`00613994529060`
Brand	NIM-Pulse®
Model	8253202
Company	Medtronic Xomed, Inc.
Product code	ETN · STIMULATOR, NERVE
Class	Class 2
FDA submission	K083124
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 17, 2023

Device type (GMDN): Nerve-locating system

An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

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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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