Rhythmlink® MRW3015Recalls & reported problems
Rhythmlink International, LLC · Disposable MR Conditional EEG Webb Electrodes · Class 2
Data updated Oct 13, 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 10816312024439), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Most reported problems
Device problems
- Material Separation1
- No Visual Prompts/Feedback1
Patient problems
- Choking1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2021Material Separation; No Visual Prompts/Feedback; Material Separation; No Visual Prompts/Feedback
RHYTHMLINK INTERNATIONAL, LLC RECEIVED NOTIFICATION FROM A CUSTOMER THAT THE HEAT SHRINK APPLIED TO THE CABLE ASSEMBLY OF AN INDIVIDUAL MR CONDITIONAL LEAD WIRE WAS SLIPPING OFF OF THE MALE DIN CONNECTOR.
Patient problems: Choking
MAUDE report 12667528 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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