Kendall 30807732 (REF 30807732-)Recalls & reported problems
Cardinal Health 200, LLC · Q-Trace 5500 Diagnostic Tab electrode -Gold, with High tac gel ( 100/PK) · 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 20192253016847), received between Mar 29, 2025 and Mar 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Sensing Problem” (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.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2025Device Sensing Problem; Device Sensing Problem
THE CUSTOMER REPORTED THAT THE ELECTRODES WERE NOT STICKING AND WERE GIVING AN INACCURATE EKG READING. ADDITIONAL INFORMATION RECEIVED ON 26MAR2025 STATED THAT THE INACCURATE EKG WAS DUE TO THE ELECTRODES NOT STICKING. THE PROVIDER WAS UNABLE TO DETERMINE IF THE PATIENT WAS HAVING A CARDIAC ISSUE. T HEY USED ANOTHER EKG MACHINE AND WAS ABLE TO GET A EKG. PATIENT CARE WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21728353 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.