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Kendall 31013926 (UDI 30884527005875)Recalls & reported problems

Cardinal Health, Inc. · 530 Foam Electrodes,Conductive Adhesive Hydrogel · 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 30884527005875), received between Oct 29, 2019 and Oct 29, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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.

Most reported problems

Device problems

  • Device Appears to Trigger Rejection1

Patient problems

  • Skin Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 29, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    THE CUSTOMER REPORTED THAT THE PATIENT WAS USING THE ELECTRODES FOR 24 HOUR HOLTER MONITORING. THE PATIENT HAD ITCHING AND SOME BURNING WHILE THE ELECTRODES WERE ON. THE ELECTRODES WERE CHALLENGING TO REMOVE AND THERE WAS REDNESS ON THE SKIN WHICH WORSENED THE NEXT DAY TO A SEVERE SKIN REACTION. THE PATIENT CONTACTED HER DOCTOR AND WAS PRESCRIBED HYDERM (1%) TOPICAL CREAM AS WELL AS MUPIROCIN 2% TOPICAL CREAM. THE PATIENT HAS NOT HAD ANY SKIN ISSUES IN THE PAST.

    Patient problems: Skin Irritation

    MAUDE report 9250757 ↗

Other Electrode, electrocardiograph devices

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