Medi-Trace Cadence 22770PC (UDI 20884527022394)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20884527022394), received between Dec 22, 2017 and Dec 26, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (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

Recent adverse event reports

The 11 most recent of 11 reports, 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 ↗
• 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 ↗
• MalfunctionJun 17, 2020Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE DEFIBRILLATION ELECTRODES ADHERED VERY POORLY. IT WAS NOT THE FIRST TIME THAT THE ADHESIVE SURFACE OR THE CONTACT GEL OF THE ELECTRODES CAME OFF WITH THE REMOVAL OF THE PROTECTIVE FOIL BUT THIS TIME IT WAS SIMPLY A BIT MORE EXTENSIVE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165432 ↗
• MalfunctionSep 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEFIB PAD WIRE UNATTACHED FROM THE PAD WHILE ATTACHED TO A PATIENT THAT WAS GIVEN DEFIBRILLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9136287 ↗
• MalfunctionSep 25, 2019Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR WIRE RIPPED OFF OF THE PAD WHILE APPLYING THE PRODUCT TO THE PATIENT. THE PRODUCT WAS NOT USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120678 ↗
• MalfunctionDec 22, 2017Gel Leak; Gel Leak

  THE CUSTOMER REPORTED THAT THE GEL FROM THE DEFIB PAD IS PEELING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7143531 ↗