ECG Electrodes 3 LEADS SET DISPOSABLE, BEDSIDE IEC RDRecalls & reported problems
Philips Medical Systems Hsg · Philips Single-Patient-Use Disposable ECG Lead Sets are intended for use only by trained healthcare professionals for measurement of a patients ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These Philips lead sets are intended for short-term use only (average patient stay of 5 days). Average lifetime of 5 days for disposable products. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 20884838075720), received between Jun 7, 2022 and Jun 7, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Overheating of Device” (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
- Adverse Event Without Identified Device or Use Problem1
- Overheating of Device1
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.
InjuryJun 7, 2022Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO PHILIPS THAT THE ELECTRODE L OF THE ECG CABLE BEGAN TO BURN THE PATIENT. THE DEVICE WAS IN USE AT TIME OF EVENT, A MINOR BURN WAS REPORTED.
Patient problems: Burn(s)
MAUDE report 14620967 ↗
Other CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices
- IntraSight 797403Philips Image Guided Therapy Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)82 reports
- ASSY, CABLE, ECG, 15 LEAD, 3 WIRE PRECOR 11111Physio-Control, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)1 recall0 reports
- MR Patient Care Short Wide ECG 2.0 Cable AAMI CAB,4 LD,CV MRI ECGPhilips Ds North America LLC · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)12 reports
- NA 5492ALMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5492VLMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5487LMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)8 reports
- NA 5487Medtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)6 reports
- CORE M2 Vascular System 400-0100.17Volcano Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)6 reports
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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