Rhythmlink® DC2415Recalls & reported problems
Rhythmlink International, LLC · 24 - 10mm, silver/silver-chloride Disposable Deep EEG Cup Electrodes · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10816312023654), received between Dec 8, 2025 and Jan 8, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Pressure Sore/Ulcer1
- Skin Discoloration1
- Skin Tears1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026
FROM STAFF: PT SEEN AT BEDSIDE IN SKIN RESPONSE FOR EVALUATION OF SUSPECTED PRESSURE INJURY TO FOREHEAD (TOP). INJURY DUE TO EEG [(ELECTROENCEPHALOGRAM)] LEAD. INJURY WAS FOUND AFTER EGG REMOVAL TODAY. WOUND APPEARS AS SHALLOW TISSUE LOSS WITH PINK WOUND BASE. EDGES ARE DEFINED AND IN THE SHAPE OF EEG LEAD. THIS INJURY IS CLASSIFIED AS A STAGE 2 PRESSURE INJURY DUE TO MECHANICAL DEVICE. RECOMMEND LEAVING AREA OTA [OPEN TO AIR] AND CONTINUE TO MONITOR AREA. WOUND TEAM WILL CONTINUE TO FOLLOW PT.
Patient problems: Skin Tears
MAUDE report 24002646 ↗InjuryDec 8, 2025Patient Device Interaction Problem
PATIENT SEEN IN SKIN RESPONSE FOR POTENTIAL PRESSURE INJURIES TO THE FOREHEAD. ELECTRODES WERE PLACED FOR EEG [ELECTROENCEPHALOGRAM] STUDY FROM [REDACTED] TO [REDACTED] - THREE DAYS LONG. ON [REDACTED] - THE LAST DAY, ELECTRODES WERE REMOVED AND 3 DISTINCT PURPLE AREAS THAT ALIGN WITH THE SHAPE OF ELECTRODES. THESE AREAS WERE IDENTIFIED AND BROUGHT TO OUR ATTENTION BY UNIT SKIN CHAMPIONS. AREAS HAVE EVOLVED FROM 3 SEPARATE AREAS OF PURPLE DISCOLORATION TO 3 AREAS OF ESCHAR WHICH ARE WELL ADHERED. GIVEN THE CHARACTERISTICS OF THE WOUNDS, THEY ARE NOW 3 UNSTAGEABLE PRESSURE INJURIES (LEFT, MIDDLE, AND RIGHT FOREHEAD). THE INFORMATION PROVIDED FOR THE DEVICE IS FROM ANOTHER SIMILAR DEVICE AS THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED BY STAFF.
Patient problems: Pressure Sore/Ulcer; Skin Discoloration
MAUDE report 23735745 ↗
Other Electrode, Cutaneous devices
- BIS 186-0106Covidien LP · Electrode, Cutaneous1 death105 reports
- RD SedLine 4248Masimo Corporation · ELECTRODE, CUTANEOUS86 reports
- Cadwell Disposable Ground Electrodes 302288-000Cadwell Industries, Inc. · ELECTRODE, CUTANEOUS1 recall0 reports
- NeuroPlus™ A10042-10Graphic Controls Acquisition Corp · Electrode, Cutaneous32 reports
- BIS 186-0200Covidien LP · Electrode, Cutaneous5 reports
- BioWave Silver Back BioWrap S/M BWRPSILVER-BACK-SMBiowave Corporation · Electrode, Cutaneous2 reports
- Bio-Logic Algo Supplies 011445Natus Medical Incorporated · Electrode, Cutaneous2 reports
- BioWave Silver Thigh-Calf BioWrap S/M BWRPSILVER-THIGH-CALF-SMBiowave Corporation · Electrode, Cutaneous1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.