Medi-Trace Cadence 22550R (UDI 20884527022332)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20884527022332), received between Jul 28, 2017 and Feb 28, 2022 — classified as 1 death, 19 malfunctions.

The most frequently reported specific device problem is “Gel Leak” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 10, 2021Sparking; Sparking

  THE CUSTOMER REPORTED THE LEAD WIRE SPARKED AND BURNED THE INSULATION ON THE WIRE OF THE DEFIB ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979043 ↗
• MalfunctionNov 16, 2020Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THERE WAS A BREAK IN THE DEFIB PAD WIRE AND THERE WAS A BURN ON THE BLANKET. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848728 ↗
• MalfunctionApr 20, 2020Device Emits Odor; Device Emits Odor

  THE CUSTOMER REPORTED THAT THE STAFF WAS PERFORMING A CARDIOVERSION WHEN THE TEAM SMELLED SOMETHING BURNING. THE TEAM WAS ABLE TO DETERMINE THAT THE BURNING SMELL WAS COMING FROM THE PATCH THAT WAS ON THE PATIENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9977919 ↗
• DeathMay 29, 2019Firing Problem; Firing Problem

  THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR WAS PLACED ON THE PATIENT AND A TRACING WAS NOTED. THE MACHINE WAS CHARGED TO 200, AND THE CUSTOMER ATTEMPTED TO DELIVER UNSUCCESSFULLY. THE CUSTOMER THEN CHARGED TO 360 AND AGAIN, THERE WAS A FAILURE OF DELIVERY. THE CUSTOMER CHANGED OUT THE PADS, AND CHARGED AND DELIVERED WITHOUT ISSUE. THE PATIENT EXPIRED DURING THE CODE EVENT BUT THE CUSTOMER STATED THEY DO NOT BELIEVE THIS WAS DIRECTLY RELATED TO THE MALFUNCTION OF THE PADS OR DELAY IN TREATMENT.

  Patient problems: Death

  MAUDE report 8649694 ↗
• MalfunctionMay 20, 2019Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE PAD GAVE A CODE "TRANSIENT AND DID NOT PICK UP". NO INJURY REPORTED. THE CUSTOMER ALSO STATED NO FURTHER INFORMATION AVAILABLE REGARDING THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624465 ↗
• MalfunctionJul 24, 2018Gel Leak; Detachment of Device or Device Component; Gel Leak

  THE CUSTOMER REPORTED THE GEL ON THE DEFIBRILLATOR PAD WAS COMING OFF.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7715604 ↗
• MalfunctionJul 24, 2018Gel Leak; Detachment of Device or Device Component; Gel Leak

  THE CUSTOMER REPORTED THE GEL ON THE DEFIBRILLATOR PAD WAS COMING OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715506 ↗
• MalfunctionApr 18, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  THE CUSTOMER REPORTED THAT THE GEL ON A DEFIBRILLATION ELECTRODE IS NOT ADHERING TO THE SKIN, WHICH WOULD CAUSE SERIOUS BURNS.

  Patient problems: Burn(s); No Known Impact Or Consequence To Patient

  MAUDE report 7441797 ↗
• MalfunctionAug 25, 2017Gel Leak; Gel Leak

  THE CUSTOMER REPORTS AS THE STAFF OPENED UP A PACK FOR A DIAGNOSTIC EP STUDY (ELECTIVE PROCEDURE), THE PAD ACTUALLY RIPPED INTO TWO PIECES WHEN SHE TRIED PULLING IT OFF THE BACKING.

  Patient problems: No Patient Involvement

  MAUDE report 6822066 ↗
• MalfunctionAug 23, 2017Delamination; Delamination

  THE CUSTOMER REPORTS THAT WHEN THE PADS WERE OPENED TO BE USED, THE CONDUCTIVE GEL CAME OFF WITH THE BACKING. THIS WAS CAUGHT PRIOR TO USE ON A PATIENT AS THIS WAS AN ELECTIVE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6815261 ↗
• MalfunctionAug 23, 2017Delamination; Delamination

  THE CUSTOMER REPORTS THAT WHEN THE PADS WERE OPENED TO BE USED, THE CONDUCTIVE GEL CAME OFF WITH THE BACKING. THIS WAS CAUGHT PRIOR TO USE ON A PATIENT AS THIS WAS AN ELECTIVE PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6815172 ↗
• MalfunctionAug 21, 2017Delamination; Delamination

  THE CUSTOMER REPORTS THAT WHEN THE PLASTIC IS REMOVED FROM THE PADS, THE GLUE IS COMING OFF. THE CUSTOMER FURTHER REPORTS THAT THIS WAS NOTICED PRIOR TO A PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6807722 ↗
• MalfunctionAug 16, 2017Delamination; Delamination

  THE CUSTOMER REPORTS THE GEL LUMPED UP ON THE PAD AND LOOKED YELLOW IN COLOR. THE GEL APPEARED THIS WAY WHEN THE CLEAR PLASTIC COVERING WAS REMOVED. THIS APPEARS WORSE WHEN THE PAD IS APPLIED TO THE PATIENT AND REMOVED.

  Patient problems: No Information

  MAUDE report 6799134 ↗
• MalfunctionAug 9, 2017Gel Leak; Gel Leak

  THE CUSTOMER REPORTS THAT WHEN THE PADS WERE OPENED TO BE USED THE CONDUCTIVE GEL CAME OFF WITH THE BACKING. THIS WAS CAUGHT PRIOR TO USE ON A PATIENT AS THESE WERE ELECTIVE PROCEDURES.

  Patient problems: No Patient Involvement

  MAUDE report 6777483 ↗
• MalfunctionJul 28, 2017Gel Leak; Gel Leak

  THE CUSTOMER REPORTS THAT THE GEL ON THE ELECTRODES IS PEELING OFF BEFORE APPLICATION TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6750842 ↗
• MalfunctionJul 28, 2017Gel Leak; Gel Leak

  THE CUSTOMER REPORTS THAT THE GEL ON THE ELECTRODES IS PEELING OFF BEFORE APPLICATION TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6750839 ↗