Medi-Trace CadenceRecalls & reported problems across all models
Cardinal Health 200, LLC · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls
- 0
We found 5 models of Medi-Trace Cadence by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2022 and Jul 28, 2026 — classified as 1 death, 2 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Sparking” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Medi-Trace Cadence problems
Device problems
- Sparking11
- Arcing of Electrodes3
- Connection Problem1
- Failure to Analyze Signal1
- Fire1
- Loss of or Failure to Bond1
- Smoking1
- Temperature Problem1
Patient problems
- Burn(s)14
- Superficial (First Degree) Burn5
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Asystole1
- Heart Failure/Congestive Heart Failure1
- Insufficient Information1
- Partial thickness (Second Degree) Burn1
Medi-Trace Cadence models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Medi-Trace Cadence 22550RAutomated external defibrillators (non-wearable)13 reports
- Medi-Trace Cadence 22770RAutomated external defibrillators (non-wearable)6 reports
- Medi-Trace Cadence 22550AAutomated external defibrillators (non-wearable)2 reports
- Medi-Trace Cadence 22550PCAutomated external defibrillators (non-wearable)1 death1 report
- Medi-Trace Cadence 22770PCAutomated external defibrillators (non-wearable)1 report
Recent Medi-Trace Cadence adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026
Patient problems: Burn(s)
MAUDE report 50058359 ↗MalfunctionJul 9, 2026
PATIENT PRESENTED TO THE CARDIAC CATH LAB FOR A CARDIOVERSION. PATIENT WAS NOTED TO HAVE HAIR ON THE CHEST THAT WAS REMOVED USING CLIPPERS PRIOR TO PAD PLACEMENT. THE PADS WERE PLACED ON A CLEAN, DRY CHEST. WHEN THE CHARGE WAS DELIVERED, THERE WAS A BRIGHT SPARK AND BURNING ODOR. WHEN THE PADS WERE REMOVED, A BURN MARK WAS NOTED IN THE MIDDLE OF THE PATIENT'S CHEST.
Patient problems: Superficial (First Degree) Burn
MAUDE report 25762612 ↗MalfunctionJun 16, 2026Sparking
THE CUSTOMER REPORTED THAT AFTER CARDIOVERTING A PATIENT, THE STAFF/PHYSICIAN NOTICED A VISIBLE SPARK COMING FROM THE PADS, SMELL OF SMOKE, AND PATIENT HAD A BURN ON THEIR SKIN IN THE SHAPE OF ONE OF THE BLACK INNER-RING CORNERS.
Patient problems: Burn(s)
MAUDE report 25526744 ↗MalfunctionJun 16, 2026Sparking
THE CUSTOMER REPORTED THAT AFTER CARDIOVERTING A PATIENT, THE STAFF/PHYSICIAN NOTICED A VISIBLE SPARK COMING FROM THE PADS, SMELL OF SMOKE, AND PATIENT HAD A BURN ON THEIR SKIN IN THE SHAPE OF ONE OF THE BLACK INNER-RING CORNERS.
Patient problems: Burn(s)
MAUDE report 25526736 ↗MalfunctionJun 16, 2026Sparking
THE CUSTOMER REPORTED THAT AFTER CARDIOVERTING A PATIENT, THE STAFF/PHYSICIAN NOTICED A VISIBLE SPARK COMING FROM THE PADS, SMELL OF SMOKE, AND PATIENT HAD A BURN ON THEIR SKIN IN THE SHAPE OF ONE OF THE BLACK INNER-RING CORNERS.
Patient problems: Burn(s)
MAUDE report 25526724 ↗MalfunctionJun 16, 2026Sparking
THE CUSTOMER REPORTED THAT AFTER CARDIOVERTING A PATIENT, THE STAFF/PHYSICIAN NOTICED A VISIBLE SPARK COMING FROM THE PADS, SMELL OF SMOKE, AND PATIENT HAD A BURN ON THEIR SKIN IN THE SHAPE OF ONE OF THE BLACK INNER-RING CORNERS.
Patient problems: Burn(s)
MAUDE report 25526710 ↗MalfunctionJun 16, 2026Sparking
THE CUSTOMER REPORTED THAT AFTER CARDIOVERTING A PATIENT, THE STAFF/PHYSICIAN NOTICED A VISIBLE SPARK COMING FROM THE PADS, SMELL OF SMOKE, AND PATIENT HAD A BURN ON THEIR SKIN IN THE SHAPE OF ONE OF THE BLACK INNER-RING CORNERS.
Patient problems: Burn(s); Superficial (First Degree) Burn
MAUDE report 25526709 ↗MalfunctionJun 16, 2026Sparking
THE CUSTOMER REPORTED THAT AFTER CARDIOVERTING A PATIENT, THE STAFF/PHYSICIAN NOTICED A VISIBLE SPARK COMING FROM THE PADS, SMELL OF SMOKE, AND PATIENT HAD A BURN ON THEIR SKIN IN THE SHAPE OF ONE OF THE BLACK INNER-RING CORNERS.
Patient problems: Burn(s); Partial thickness (Second Degree) Burn
MAUDE report 25526679 ↗MalfunctionApr 29, 2026Sparking
THE CUSTOMER REPORTED THAT THE PADS SPARKED DURING RESUSCITATION AND HAD TO BE REMOVED FROM PATIENT. ADDITIONAL INFORMATION RECEIVED ON 24APR2026 STATED THAT THERE WAS NO DELAY IN CARE OR IMPACT TO PATIENT NOTED. THEY WERE ABLE TO CONTINUE ACLS CODE PROTOCOL WITHOUT INTERRUPTION. PATIENT DID HAVE A SMALL 2-3INCH MARK ON SKIN FOLLOWING EVENT. PATIENT'S SKIN WAS CLEAN, DRY, AND INTACT AND PREPPED PROPERLY PRIOR TO PLACEMENT OF PADS AND PATIENT WAS NOT WEARING JEWELRY AT TIME OF EVENT. UNKNOWN IF OXYGEN WAS BEING USED. PATIENT EXPIRED WHICH WAS UNRELATED TO THE REPORTED PRODUCT OR EVENT.
Patient problems: Burn(s)
MAUDE report 25036697 ↗MalfunctionMar 12, 2026Arcing of Electrodes
THE CUSTOMER REPORTED THAT WHILE BEING USED ON A PATIENT, THE SET OF PADS ARCED AND SHOT FLAMES OUT OF THEM. THE PATIENT WAS PROPERLY PREPPED, SHAVED, AND HAD NO JEWELRY OR OTHER ITEMS ON THAT ONE WOULD REASONABLY CONSIDER TO BE A CONTRIBUTING FACTOR.
Patient problems: Insufficient Information
MAUDE report 24584717 ↗MalfunctionNov 20, 2025Smoking; Smoking
THE CUSTOMER REPORTED THAT THE PADS WERE PLACED ON PATIENT AND IT BEGAN SMOKING. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610049 ↗MalfunctionNov 5, 2025Sparking; Sparking
THE CUSTOMER REPORTED THAT THE ICU AT THE GENERAL HAS HAD A PATIENT RECEIVE BURNS WHILE USING THE PAD RADIOLUCENT MEDI-TRACE, PRODUCT CODE Z22770R. LOT NUMBER IDENTIFIED IS 515520X. BIOMED HAS TESTED THE DEFIBRILLATOR AND FOUND NO ISSUES, IT WAS THE PAD ITSELF THAT SPARKED. MSICU ZOLL CHARGE TO 200J AND SYNCHRONIZED. SHOCK ADMINISTERED WITH SUCCESSFUL RHYTHM CHANGE. HOWEVER, WHEN CARDIOVERSION WAS PERFORMED, SPARK NOTED TO OCCUR TO ANTERIOR TRANSCUTANEOUS PAD. ON FURTHER ASSESSMENT SUPERFICIAL BURN NOTED TO PATIENTS' CHEST IN THE SHAPE OF THE TRANSCUTANEOUS PAD. USE OF TRANSCUTANEOUS PAD DISCONTINUED AT THIS TIME WITH (POTENTIALLY) FAULTY TRANSCUTANEOUS PAD PUT ASIDE IN MISCU CN OFFICE. ON (B)(6) 2025 THE CUSTOMER STATED THE PATIENT'S TREATMENT CONSIDERED OF POLYSPORIN TOPICALLY.
Patient problems: Superficial (First Degree) Burn
MAUDE report 23480297 ↗InjuryNov 3, 2025Fire; Fire
THE CUSTOMER REPORTED THAT THE PADS WERE ON A PATIENT AND STARTED TO SMOKE AND CAUGHT ON FIRE, BURNING THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 15OCT2025 STATED THAT THE FIRE STARTED FROM A SPARK COMING FROM THE PAD DURING A CARDIOVERSION. THE FIRE SPREAD UP TO THE PATIENT'S FACE, CHEST, AND NECK AREA. THERE WERE BURNS TO THE FACE (CHECKS, LIPS, NOSE, NASAL PASSAGE, LOWER FOREHEAD), UPPER CHEST, NECK, UPPER BACK, AND RIGHT SHOULDER. THE PATIENT REQUIRED IMMEDIATE INTUBATION DUE TO AIRWAY CONCERNS AS WELL AS SMOKE INHALATION AND VISIBLE BURNS TO NASAL PASSAGE. THE DEGREE OF THE PATIENT'S BURNS ARE NOT KNOWN AS THE PATIENT WAS TRANSFERRED TO ACUTE CARE BURN CENTER FOR FURTHER TREATMENT BECAUSE THE BURNS WERE TOO ADVANCED FOR THE CARE THAT THE REPORTING FACILITY WAS ABLE TO PROVIDE. THE STATUS OF THE PATIENT IS UNKNOWN, BUT THEY HEARD HE WAS DOING WELL; HOWEVER, THEY ARE UNABLE TO VALIDATE THAT INFORMATION. THE INITIAL REPORTER BELIEVES THE PATIENT WAS PREPPED PER THE IFU. THE FIRE WAS SUPPRESSED BY SUFFOCATING WITH A PILLOW. OTHER DEVICES BEING USED DURING THE EVENT: OXYGEN, CARDIAC MONITOR, AND LIFEPACK.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s)
MAUDE report 23459204 ↗MalfunctionOct 7, 2024Sparking; Sparking
THE CUSTOMER REPORTED THEY HAD A CODE BLUE INCIDENT WHERE A PATIENT REQUIRED MEDICAL INTERVENTION USING A LIFEPAK 20E DEFIBRILLATOR. THE CLINICAL USERS INDICATED WHEN ADMINISTERING A SHOCK, THE PATIENT WAS BURNT AND SPARKING WAS HAPPENING ON THE ELECTRODE, MOST LIKELY FROM THE CONNECTION FROM THE WIRES TO THE ELECTRODE PAD. THE CLINICAL USERS STATED THEY DID NOT HAVE ISSUES ATTACHING THE PAD TO THE PATIENT AND THE PATIENT DID NOT HAVE A LOT OF HAIR ON THEIR BODY. THE PRODUCT WAS STICKING FINE. THE CUSTOMER STATED THAT THEY SAW THAT THE QUIK-COMBO THERAPY CABLE THAT CONNECTS FROM THE DEFIBRILLATOR TO THE ELECTRODES HAD NOT BEEN REPLACED IN A WHILE, WHICH THEY BELIEVE THEY TYPICALLY REPLACE THOSE EVERY 3 YEARS SO THAT PART WAS REPLACED. THEY DID NOT OBSERVE ANY BURNING OR DEFECTS ON THE EXTERIOR OF THE QUIK-COMBO. THEY LOOKED OVER THE DEFIBRILLATOR AND COULD NOT FIND AN ISSUE AS THERE WERE NO ERROR CODES ON THE DEVICE. THE CUSTOMER FURTHER STATED THAT THEY WERE ABLE TO ADMINISTER SHOCKS AFTER THEY SWAPPED FOR NEW PADS AND DEFIBRILLATOR; THE PATIENT EVENTUALLY EXPIRED DUE TO OTHER UNDERLYING PROBLEMS NON-RELATED TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 07OCT2024 STATED THAT O
Patient problems: Burn(s)
MAUDE report 20392619 ↗MalfunctionApr 23, 2024Connection Problem; Connection Problem
THE CUSTOMER REPORTED THAT WHEN USING THE DEVICE, THE PLATE CONNECTOR WAS NOT ATTACHED TO THE DEFIBRILLATOR. THE CONNECTOR APPEARED BENT AND THAT PREVENTED IT FROM CONNECTING. THE CUSTOMER FURTHER STATED THAT THE DEVICE HAD BEEN STORED PROPERLY AND THE PACKAGING WAS OPENED AT THE TIME OF USE. THERE WAS NO HARM TO THE PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PART INVOLVED IN THE ISSUE WAS A BEND IN THE FIRST METAL PIN, THE ONE NEAR THE FIXING TAB (THE FIRST FROM THE TOP) INSIDE ITS PROTECTIVE PART, WHICH WAS NEITHER CRUSHED NOR DAMAGED. IT WAS FOLDED AND RESTING AGAINST THE WALL OF THE PROTECTION AND PREVENTED IT FROM FITTING ONTO THE CABLE SOCKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163224 ↗
Other Cardinal Health 200, LLC products
- JACKSON-PRATT20 models · 13 reports · 19 recalls
- Monoject35 models · 96 reports · 11 recalls
- CONVERTORS38 models · 40 reports · 11 recalls
- Argyle33 models · 58 reports · 7 recalls
- Salem Sump31 models · 40 reports · 7 recalls
- Dover45 models · 241 reports · 2 recalls
- Kendall31 models · 51 reports · 3 recalls
- Kangaroo35 models · 130 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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