CARDINAL HEALTH E510DATMRecalls & reported problems
Cardinal Health 200, LLC · Monitoring Electrode, Stmls Stl Snap, Diaphoretic, Foam, Tear Drop · Class 2
- 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 30885380074534), received between May 18, 2017 and May 18, 2017 — classified as 1 malfunction.
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
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ELECTRODES WERE USED FOR A CATH LAB PROCEDURE AND A FEW DAYS LATER, MARKS SHOWED UP ON THE PATIENTS BODY.
Patient problems: Skin Irritation
MAUDE report 6576946 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.