Medi-Trace Cadence 22550A (UDI 20884527022301)Recalls & reported problems
Cardinal Health, Inc. · Adult Multi-Function Defibrillation Electrodes · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884527022301), received between Jul 31, 2018 and Jun 3, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (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.
Most reported problems
Device problems
- Defibrillation/Stimulation Problem2
- Detachment of Device or Device Component1
- Material Integrity Problem1
- Sparking1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2021Sparking; Sparking
THE CUSTOMER REPORTED THE DEFIB ELECTRODES WAS SPARKING DURING TREATMENT OF A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11931395 ↗MalfunctionJun 2, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DO SYNCHRONIZED CARDIO-VERSION BECAUSE THE DEFIBRILLATOR ELECTRODES DID NOT RECOGNIZE THE T WAVE ON THE EKG AND DID NOT SEND A SIGNAL TO SHOCK. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10112318 ↗MalfunctionJun 2, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DO SYNCHRONIZED CARDIO-VERSION BECAUSE THE DEFIBRILLATOR ELECTRODES DID NOT RECOGNIZE THE T WAVE ON THE EKG AND DID NOT SEND A SIGNAL TO SHOCK. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10112315 ↗MalfunctionJul 31, 2018Detachment of Device or Device Component; Material Integrity Problem; Material Integrity Problem
THE CUSTOMER REPORTED THE GEL IS DETACHED FROM THE ELECTRODE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7736844 ↗
Other Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.