Medi-Trace CadenceRecalls & reported problems across all models

We found 9 models of Medi-Trace Cadence by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2017 and Dec 26, 2025 — classified as 2 deaths, 1 injury, 52 malfunctions.

The most frequently reported specific device problem is “Gel Leak” (9 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

Most reported Medi-Trace Cadence problems

Medi-Trace Cadence models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Medi-Trace Cadence 22550R

  Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
  1 death20 reports
• Medi-Trace Cadence 22770PC

  Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
  11 reports
• Medi-Trace Cadence 22550PC

  Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
  8 reports
• Medi-Trace Cadence 22770R

  Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
  5 reports
• Medi-Trace Cadence 22550A

  Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
  4 reports
• Medi-Trace Cadence 22660R

  Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
  1 death4 reports
• Medi-Trace Cadence 22660PC

  Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
  1 report
• Medi-Trace Cadence 22661R

  Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
  1 report
• Medi-Trace Cadence 22770P

  PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
  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.

• MalfunctionDec 26, 2025Arcing of Electrodes; Arcing of Electrodes

  THE CUSTOMER REPORTED THERE WAS A PATIENT IN VFIB REQUIRING DEFIBRILLATION, PADS PUT ON PATIENT AND SHOCKED C 200J. AUDIBLE POPPING AND NOISE HEARD, SMELL OF SOMETHING BURNING/SMOKING. PATIENT SUCCESSFULLY DEFIBRILLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896100 ↗
• MalfunctionNov 22, 2023Arcing of Electrodes; Arcing of Electrodes

  THE CUSTOMER REPORTED THE DEFIB PADS ARCED, AND THE PATIENT RECEIVED A MINOR BURN. THIS HAS BEEN REPORTED IN MEDWATCH. THE PATIENT DID NOT REQUIRE ANY TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 18192205 ↗
• MalfunctionNov 22, 2023Arcing of Electrodes; Arcing of Electrodes

  THE CUSTOMER REPORTED THE DEFIB PADS ARCED, AND THE PATIENT RECEIVED A MINOR BURN. THIS HAS BEEN REPORTED IN MEDWATCH. THE PATIENT WAS TREATED WITH POLYSPORIN AND 2X2.

  Patient problems: Burn(s)

  MAUDE report 18192031 ↗
• InjurySep 19, 2023No Pacing; No Pacing

  CUSTOMER REPORTS: THE CLIENT NEEDED TO USE THE MULTIFUNCTION ELECTRODES TO DO EXTERNAL PACING TO A PATIENT AND IT DID NOT WORK. THE ELECTRODE GENERATED NO PULSE. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2023, DESPITE THE FREQUENCY OF ZOLL SET AT 60 BPM, THE PATIENT REMAINED BRADYCARDIUM AT 30 BPM (FEMORAL PULSE). THE ELECTRODE SEEMED TO RECEIVE A SIGNAL BECAUSE WE SAW SPICULE AT THE MONITOR. WE INSTALLED THE ELECTRODES TO DO EXTERNAL PACING AND NOT DEFIBRILLATION. THE SIGNAL WAS INACCURATE BECAUSE THE PULSE REQUESTED AT THE ZOLL WAS 60 BPM, BUT THE PATIENT REMAINED WITH A FEMORAL PULSE OF 30 BPM. THERE WAS A DELAY TO TREATMENT, BUT NOT IN DEFIBRILLATION BUT RATHER IN RESTORING THE PATIENT'S PULSE. WE HAD TO INSTALL A TEMPORARY ENDOVENOUS PACEMAKER FOR THE PATIENT AND WE HAD TO PUT ISUPREL AND DOPAMINE. THE PATIENT WAS DISCHARGED.

  Patient problems: Bradycardia

  MAUDE report 17777709 ↗
• MalfunctionMay 31, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE PRODUCT WAS HOOKED UP TO A LIFEPAK15 AND IT DIDN'T DEFIBRILLATE. THE PATIENT WAS OK. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THE PATIENT WAS UNDER PROLONGED ANESTHESIA DUE TO THE TIME TAKEN TO TROUBLESHOOT THE DEFIBRILLATOR AND APPLY NEW 3RD PARTY DEFIBRILLATOR PADS. OTHERWISE, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS IT WAS IN A CONTROLLED ENVIRONMENT FOR A CARDIOVERSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547022 ↗
• MalfunctionFeb 28, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED STRAIGHT OUT OF THE PACKAGE, THERE WAS A NOTICEABLE CUT/TEAR IN THE WIRE. THE PAD WAS REPLACED IMMEDIATELY. THERE WAS NO HARM TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619342 ↗
• MalfunctionFeb 23, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE PRE-CONNECT DEFIBRILLATION ELECTRODE FAILED TO DISCHARGE A CHARGE TO A PATIENT DURING CODE BLUE AND A SMART DEFIBRILLATOR WAS USED DURING THE INCIDENT. THE INTERNAL ONSITE HOSPITAL DEPARTMENT BIOMED (EQUIPMENT MANAGEMENT TEAM, INCLUDING QUALITY ASSURANCE (QA), MATERIAL) DID TESTING ON 22770PC (LOT # 121672X) AND THE SAMPLES WERE DISCHARGED PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 13586825 ↗
• MalfunctionFeb 23, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEFIBRILLATION CHARGE NOT HAPPENED TO A PATIENT DURING CODE BLUE AND A SMART DEFIBRILLATOR WAS USED DURING THE INCIDENT. THE INTERNAL ONSITE HOSPITAL DEPARTMENT BIOMED (EQUIPMENT MANAGEMENT TEAM, INCLUDING QUALITY ASSURANCE (QA), MATERIAL) DID TESTING ON (B)(4) (LOT # 226434X) AND THE SAMPLES WERE DISCHARGED PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 13586736 ↗
• MalfunctionFeb 23, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEFIBRILLATION ELECTRODE FAILED TO DISCHARGE A CHARGE TO PATIENT DURING CODE BLUE AND A SMART DEFIBRILLATOR USED DURING THE INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT EXPIRED. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 13586720 ↗
• MalfunctionDec 14, 2021Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT HALF OF THE CONDUCTIVE JELLY APPEARS TO STICK TO THE DISPOSABLE PART INSTEAD OF ON THE PATIENT. ADDITIONAL INFORMATION PROVIDED STATED THAT THERE WAS NO PATIENT HARM OR DELAY. THIS ISSUE OCCURRED DURING A PATIENT CASE AND WAS NOTICED PRIOR TO PUTTING THE PADS ON THE PATIENT; THE PRODUCT WAS NOT USED. THE CUSTOMER THEN OPENED EVERYTHING THEY HAD LEFT IN STOCK. THESE WERE DEFIB PADS THAT THE CUSTOMER HAPPENED TO FIND IN THEIR WAREHOUSE AFTER THEIR CURRENT SUPPLIER HAD A BACKORDER. THE DEFIB PADS WERE LAST ORDERED FROM US IN 2019. THE CUSTOMER STATED THAT THEY KNEW THE PRODUCT WAS PAST THE EXPIRATION DATE (AUGUST 2020) BUT SINCE THEY DID NOT HAVE ANY OTHER OPTION, THEY TRIED TO USE THEM UNTIL THEY NOTICED THAT THE JELLY WAS NOT WORKING/WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006426 ↗
• 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 ↗
• MalfunctionAug 23, 2021Sparking; Sparking

  THE CUSTOMER REPORTED THAT A NURSE PLACED ELECTRODES ON PATIENT. WHEN THE DEFIB WAS USED, THE ELECTRODE BURNT THE PATIENT IN A U SHAPED BURN PATTERN. THE NURSE STATED HE ACTUALLY SAW A FLASH OF SPARKS COME FROM THE ELECTRODE AREA WHILE SHOCKING THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 13-AUG-2021 STATES THAT A CARDIOVERSION WAS BEING PERFORMED WITH A MEDTRONIC LIFEPACK 20E. THE INSTRUCTIONS FOR SKIN PREP WERE FOLLOWED PROPERLY. THE AREA OF PAD PLACEMENT WAS FREE OF HAIR AND DRY. THE PADS WERE PLACED FLUSH ON THE SKIN AND WERE IN PLACE FOR 20 MINUTES PRIOR TO DELIVERING ONE SHOCK AT 360 JOULES. THE FIRST DEGREE (SUPERFICIAL) BURN WAS UNDER THE ANTERIOR PAD ONLY. IT WAS APPROXIMATELY 1-1.5 CM FROM THE EDGE OF THE PAD AND DID NOT REQUIRE TREATMENT. NASAL PRONGS WERE IN USE ON THE PATIENT DURING THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356690 ↗
• MalfunctionAug 23, 2021Sparking; Sparking

  THE CUSTOMER REPORTED THAT THE PATIENT SCHEDULED TO HAVE A CARDIOVERSION. WHEN ENERGY WAS DELIVERED, A SPARK OCCURRED ON THE CABLE FROM THE DEFIBRILLATOR. THE PATIENT'S SKIN WAS CHECKED WITH NO SKIN IRRITATION OR BURN NOTED. THE PATIENT WAS CARDIOVERTED SUCCESSFULLY DURING THE PROCEDURE. OTHERWISE NORMAL RECOVERY AND DISCONTINUE WITHOUT ISSUE. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354483 ↗
• MalfunctionJul 29, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE PATIENT WAS IN FIBRILLATION FOLLOWING THE CEC, THEREFORE DEFIBRILLATION WAS NECESSARY. THE NURSE ATTEMPTED TO DEFIBRILLATE THE PATIENT WITH THE EXTERNAL PADS, WITHOUT SUCCESS. THEY USED INTERNAL PADDLES TO DEFIBRILLATE THE PATIENT. THE PATIENT DID NOT SUFFER FROM THE INCIDENT AS THEY QUICKLY USED THE INTERNAL PADDLES. THE EMERGENCY INTERNAL DEFIBRILLATION RESOLVED THE ISSUE. ADDITIONAL INFORMATION PROVIDED ON JULY 26, 2021 STATED THAT THE PROCEDURES BEING PERFORMED WERE X2 CORONARY ARTERY BYPASS GRAFTING (CABG) AND 2X MAMMARY CORONARY BYPASS SURGERY. THE THORAX WAS ALREADY OPEN WHEN THE INTERNAL PADDLES WERE USED BECAUSE THE SURGERY WAS TAKING PLACE. CEC REFERS TO EXTRACORPOREAL CIRCULATION. THERE WAS A THREE MINUTE DELAY IN DEFIBRILLATION. THERE WAS NO OTHER MEDICAL TREATMENT OR INTERVENTION REQUIRED. THE PATIENT'S CURRENT STATUS IS NORMAL. ADDITIONAL INFORMATION PROVIDED ON JULY 28, 2021 STATED THAT THE MACHINE DID NOT DETECT THE PADS, THEREFOR THE PADS COULD NOT DELIVER THE SHOCK. ADDITIONAL INFORMATION PROVIDED ON JULY 29, 2021 STATED THAT THE DEFIBRILLATOR MODEL USED WAS A LIFEPAK 15 FROM STRYKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247867 ↗
• MalfunctionJun 23, 2021Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER REPORTED THEY THE DEFIB PADS WERE ONLY BEING USED TO MONITOR AT THE TIME BUT WOULD NOT PICK UP AN ELECTRICAL ACTIVITY. THEY WERE REMOVED AND ANOTHER SET WAS PLACED THAT WORKED APPROPRIATELY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051464 ↗

Other Cardinal Health, Inc. products

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• Argyle64 models · 459 reports
• Magellan29 models · 445 reports
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