Medi-Trace Cadence 22550R (REF 22550R-)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20192253017585), received between Jun 23, 2022 and Jun 16, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Sparking” (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, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 17, 2023Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER REPORTED THAT THE ECG LEAD WAS NOT POSSIBLE, THERE WAS NO DATA. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS ONLY ONE PATIENT INVOLVED. THE FIRST PAIR OF ELECTRODES DIDN¿T WORK, THEY TOOK THE SECOND PAIR, IT ALSO DIDN¿T WORK AND THEN THEY TOOK A PAIR OF ORIGINAL PHYSIO-CONTROL ELECTRODES, WHICH WORKED WELL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949084 ↗
• MalfunctionApr 7, 2023Arcing of Electrodes; Arcing of Electrodes

  THE CUSTOMER REPORTED THAT DURING THE PLANNED ELECTRICAL CARDIOVERSION OF THE PATIENT WITH ATRIAL FIBRILLATION, AN AUDIBLE BANG OCCURRED WHEN A CURRENT OF 360 J WAS DELIVERED, FOLLOWED BY A BURNT SMELL AND BURNING OF THE SKIN ON THE LEFT SIDE OF THE PATIENT. PER CUSTOMER, FROM A SURGICAL POINT OF VIEW, A SLIGHT BURN. THE BURN ON THE PATIENT¿S SKIN HAD AN ELONGATED CURVED SHAPE, SIMILAR TO A BOOMERANG. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS A BANG AND A SMELL OF BURNING NOTICED WITH THE DEFIB PADS. IT WAS UNKNOWN, IF THERE WAS ANY MEDICAL INTERVENTION OR TREATMENT PROVIDED FOR THE SKIN BURN.

  Patient problems: Burn(s)

  MAUDE report 16704071 ↗
• MalfunctionJun 23, 2022Sparking; Sparking

  THE CUSTOMER REPORTED THERE IS AN ERYTHEMA WHERE THE ELECTRODE HAS BEEN PLACED. ADDITIONAL INFORMATION RECEIVED STATED WHEN THE SHOCK IS APPLIED DURING ELECTRICAL CARDIOVERSION, SPARKS JUMP IN THE ANTERIOR ELECTRODE, PRODUCING A SKIN BURN THAT WILL REQUIRE FOLLOW-UP AND TREATMENT IN PRIMARY CARE. THE CUSTOMER HAS OBSERVED THIS IN THE DIFFERENT CARDIOLOGY DEPARTMENTS SINCE USING THE MEDI-TRACE PATCH.

  Patient problems: Burn(s)

  MAUDE report 14788903 ↗
• MalfunctionJun 23, 2022Sparking; Sparking

  THE CUSTOMER REPORTED THERE IS AN ERYTHEMA WHERE THE ELECTRODE HAS BEEN PLACED. ADDITIONAL INFORMATION RECEIVED STATED WHEN THE SHOCK IS APPLIED DURING ELECTRICAL CARDIOVERSION, SPARKS JUMP IN THE ANTERIOR ELECTRODE, PRODUCING A SKIN BURN THAT WILL REQUIRE FOLLOW-UP AND TREATMENT IN PRIMARY CARE. THE CUSTOMER HAS OBSERVED THIS IN THE DIFFERENT CARDIOLOGY DEPARTMENTS SINCE USING THE MEDI-TRACE PATCH.

  Patient problems: Burn(s)

  MAUDE report 14788721 ↗