Medi-Trace Cadence 22661RRecalls & reported problems
Cardinal Health, Inc. · Adult Multi-Function Defibrillation Electrodes, Radiotransparent · Class 2
All models of Medi-Trace Cadence (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 20884527022370), received between Jun 11, 2021 and Jun 11, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
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.
MalfunctionJun 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE CUSTOMER REPORTED THAT THEY HAD AN INCIDENT WHERE A DEFIB PATCH WAS NOT STICKING TO THE PATIENT DURING THE PROCEDURE. THE CUSTOMER STATED THAT THE EP TEAM WAS ROLLING THE PATIENT BACK ON HIS BED WHEN THEY NOTICED THAT THE R2 PATCH WAS NOT STUCK TO THE PATIENT. THE PATIENT WAS FREE OF HAIR AND MOISTURE. ADDITIONAL INFORMATION RECEIVED ON 4-JUN-2021 STATED THAT THE PROCEDURE BEING PERFORMED WAS A EP ABLATION AND CARDIAC CATH. THE PADS HAD BEEN PLACED IN CASE FOR THE PROCEDURE, THEY DID NOT NEED TO SHOCK THE PATIENT. THE PROCEDURE WAS OVER WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO DELAY IN TREATMENT AND NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11988044 ↗
Other Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) devices
- Tempus LS-MANUAL 3.940589Schiller AG · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)4 recalls34 deaths391 reports
- M SERIES BIPHASIC 40010011100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 death247 reports
- M SERIES BIPHASIC 40010511100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)77 reports
- M SERIES BIPHASIC 40010011100103011Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)48 reports
- Medi-Trace Cadence 22550RCardinal Health, Inc. · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)1 death20 reports
- M SERIES BIPHASIC 40010711100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)14 reports
- Medi-Trace Cadence 22770PCCardinal Health, Inc. · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)11 reports
- M SERIES BIPHASIC 60010011100123010Zoll Medical Corporation · PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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