Rhythmlink® MRQD3090409015Recalls & reported problems

Rhythmlink International, LLC · 3 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable [22 Pack] · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816312026719), received between Nov 19, 2025 and Nov 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1

Patient problems

Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryNov 19, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON (B)(6) 2025 A PATIENT WAS TAKEN TO COMPLETE A MRI PROCEDURE. THE SECTION OF THE NON-MRI-CONDITIONAL CABLING LABELED "MR UNSAFE" ATTACHED TO RHYTHMLINK PART NUMBER MRQD309040915 WAS NOT DISCONNECTED AS REQUIRED BY THE INSTRUCTIONS FOR USE AND REMAINED ATTACHED TO THE PATIENT DURING THE MRI, RESULTING IN TWO BURNS FROM THE NON-MRI CONDITIONAL CABLING.
Patient problems: Burn(s)
MAUDE report 23596035 ↗

Device details

UDI-DI	`00816312026719`
Brand	Rhythmlink®
Model	MRQD3090409015
Company	Rhythmlink International, LLC
Product code	GXY · Electrode, Cutaneous
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 1, 2023

Device type (GMDN): Analytical scalp electrode, single-use

A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.