Medline MDS61115RRecalls & reported problems
Medline Industries, Inc. · ELECTRODE,NEONATE,RADIOTRANSLUCENT,1.5MM · Class 2
Data updated Oct 18, 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 10884389114872), received between Jan 29, 2018 and Feb 6, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Component Missing2
- Defective Component1
- Device Packaging Compromised1
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2018Component Missing
ECG LEADS RECEIVED IN RISK MANAGEMENT DEPT. IT WAS NOTED THAT THE INDENTATION MARKINGS ARE MISSING FROM WHITE LEAD; NOT ABLE TO PLUG INTO ECG CORD.
Patient problems: No Information
MAUDE report 7244220 ↗MalfunctionJan 29, 2018Defective Component; Component Missing; Device Packaging Compromised
EKG LEADS FOUND TO BE DEFECTIVE IN MULTIPLE PACKAGES. WHITE END CAP OF THE LEAD MISSING INDENTATION TO CORRECTLY FIT INTO CABLE TO PROVIDE CORRECT CONNECTION.
Patient problems: No Information
MAUDE report 7224868 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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