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Kendall EP30016Recalls & reported problems

Cardinal Health, Inc. · ECG Electrodes,H34LG, Foam, Wet Gel, Snap, Diagnostic, Stress · Class 2

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 20884527005069), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

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.

  • InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED THAT A BABY LESS THAN 26 WEEKS GESTATIONAL AGE AT BIRTH AND LESS THAN A WEEK OLD THE DAY OF THE EVENT HAD WHAT LOOKED LIKE A CHEMICAL BURN. THE NURSE STATED THAT REDNESS WAS NOTED WHEN THEY MOVED THE ELECTRODE AND THE BURN WAS NOTED WITHIN AN HOUR OF THE ELECTRODE BEING RELOCATED FROM THE AFFECTED AREA. THE NURSE STATED THEY CHANGED THE LEADS AT LEAST 1-2 TIMES PER SHIFT DUE TO THE HIGH HUMIDITY ENVIRONMENT. PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER REPORTED THAT THE PATIENT RECEIVED NYSTATIN AFTER MEPILEX OR HYDROFERA BLUE FOR TREATMENT.

    Patient problems: Burn(s)

    MAUDE report 12455510 ↗

Other Electrode, electrocardiograph devices

All Electrode, electrocardiograph devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.