ECG Cables and Leadsets Preattached leadwire electrode, SquareRecalls & reported problems
Philips Medical Systems Hsg · Preattached leadwire electrode, Square Radiolucent carbon AAMI color 45cm/18" leadwires with 1.5mm/.060" safety socket square 22cm x 22cm cloth backing with Ag/Cl sensor, 3/pouch, 300/case. · Class 2
Data updated Oct 18, 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 20884838006793), received between Jun 3, 2019 and Jun 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gel Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Gel Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2019Gel Leak
THE CUSTOMER REPORTED THAT THE GEL SEPARATED FROM THE ELECTRODE, THE CHILD PUT THE GEL INTO HIS MOUTH. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8663110 ↗
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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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