Kendall 31.1925.21Recalls & reported problems
Cardinal Health 200, LLC · Kendall H92SG ECG ELECTRODES, Foam Hydrogel 57 x 34 mm · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20192253016984), received between Jan 10, 2023 and Oct 24, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED INACCURATE AND INCONSISTENT READING FROM THE ELECTRODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17994718 ↗MalfunctionSep 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE DOCTOR HAS ADVISED THE ELECTRODE GIVES THE INCORRECT READING AND IS CAUSING AN INTERFERENCE ON THE ECG THAT LOOKS LIKE ATRIAL FIBRILLATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17715997 ↗InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE PATIENT HAD A LONG-RANGE ELECTROCARDIOGRAM FOR HEART DISEASE, AND THE SKIN COVERED BY THE ELECTRODES BECAME RED WITH SKIN LESIONS, SO THE ELECTRODES WERE STOPPED, AND ERYTHROMYCIN OINTMENT WAS APPLIED TO THE SKIN.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16134910 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.