Medi-Trace Cadence 22770R (UDI 20884527022400)Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884527022400), received between Mar 27, 2020 and Sep 28, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Arcing” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Arcing3
- Device Emits Odor1
- Device Sensing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Burn(s)1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2021Device Sensing Problem; Device Sensing Problem
THE CUSTOMER REPORTED THEIR PATIENT WAS A MAN WITH A HEART BLOCK AND DECREASED BP. THEY WERE UNABLE TO GET CAPTURE WITH TRANS CUTANEOUS PACING. THEY TRIED MULTIPLE PADS, MULTIPLE PAD PLACEMENTS, AND MULTIPLE ZOLL MACHINES. THERE WAS NO PATIENT DISCOMFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12540252 ↗MalfunctionJun 17, 2021Arcing; Arcing
THE CUSTOMER REPORTED THAT ARCING OCCURRED, BLACK RESIDUE AROUND RIM WAS OBSERVED. THE BLACK RESIDUE WAS LEFT ON PATIENT WHICH WAS ABLE TO BE WIPED OFF. THERE WAS SMOKE COMING FROM THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12018427 ↗MalfunctionJun 10, 2021Arcing; Arcing
THE CUSTOMER REPORTED THEY HAD A SET OF PADS THAT ARCHED AND SMOKED A LITTLE WHEN THE PATIENT WAS CARDIOVERTED. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED: THE ARCHING/SMOKE WAS SEEN AT THE DISTAL END OF THE PADS WHERE THE WIRES ENTER THE PAD. THE CARDIOVERSION WAS SUCCESSFUL IN DELIVERING 200 JOULE SHOCKS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11979331 ↗MalfunctionMay 28, 2021Arcing; Arcing
THE CUSTOMER REPORTED THAT ARCING OCCURRED WITH THE DEFIBRILLATION ELECTRODES. THERE WERE NO BURNS TO THE PATIENT'S SKIN AND THE PATIENT SEEMED TO BE UNHARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11901191 ↗MalfunctionMar 27, 2020Device Emits Odor; Device Emits Odor
THE CUSTOMER REPORTED THAT THE DEFIBRILLATION PATCHES WERE APPLIED ANTERIOR/POSTERIOR TO CHEST AND BACK AND CONNECTED TO A DEFIBRILLATOR, AFTER THE INITIAL SHOCK OF 150 JOULES AND UNSUCCESSFUL CARDIOVERSION THE STAFF NOTICED A FAINT BURNING SMELL AND HEARD A POP. THE PAD PLACEMENT AND ADHERENCE WERE CHECKED AND AGREE TO BE CORRECTLY PLACED AND ADHERED. THE SECOND SHOCK WAS DELIVERED AT 200 JOULES, CARDIOVERSION WAS SUCCESSFUL WITH SIMILAR RESULT OF BURNING SMELL. AFTER THE PADS WERE REMOVED THE PATIENT WAS FOUND TO HAVE SMALL BURN MARKS ON MID-CHEST BUT NONE ON THE BACK. THE PROMINENT BURN MARK WAS APPROXIMATELY 4 CM LONG WITH SEVERAL SMALLER MARKS SCATTERED WHERE THE EDGE OF THE PAD HAD BEEN. SILVADINE WAS APPLIED TO THE AREA PER PHYSICIAN'S ORDER.
Patient problems: Burn(s)
MAUDE report 9891812 ↗
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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