Kendall 22930Recalls & reported problems
Cardinal Health 200, LLC · Kendall Radiolucent Foam Monitoring electrode Teardrop shape · 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 20192253016779), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT WHEN THE ELECTRODE IS REMOVED FROM THE WIRE THAT IS CONNECTED TO THE HOLTER, THE BLACK TIP REMAINS IN THE PLUG AND MUST BE REMOVED BY REMOVING IT WITH A CHISEL OR PAPER CLIP. IN ADDITION, BLACK REMAINS INSIDE THE TIP OF THE PLUG AND THE STAFF HAVE TO TAKE A PAPER CLIP TO TRY TO REMOVE EVERYTHING, BUT DAMAGE IS STARTING TO OCCUR ON MANY OF THE WIRINGS. THIS HAS BEEN OCCURRING ON A DAILY BASIS FOR SEVERAL MONTHS. FURTHERMORE, ARTIFACTS HAVE BEEN MORE PRESENT FOR A FEW WEEKS ON THE HOLTERS AND EXAMINATIONS ARE 4X LONGER TO DECODE, AND SOME ARRHYTHMIA COULD NOT BE SPOTTED UNDER THE ARTIFACTS. ON 16SEP2025 CUSTOMER STATED THAT NO PATIENTS WERE INJURED. HOWEVER, THE ELECTRODE WIRES BECOME DAMAGED WHEN ATTEMPTING TO REMOVE THE BLACK TIP INSIDE THE ELECTRODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302883 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.