Medi-Trace Cadence 22550PC (UDI 20884527022325)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884527022325), received between Feb 20, 2018 and May 31, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 1, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THIS INCIDENT OCCURRED IN MID FEBRUARY ON A PATIENT WITH ATRIAL FIBRILLATION FOR CARDIOVERSION THERAPY. THE PATIENT WAS MONITORED WITH MEDI-TRACE CADENCE PRE-CONNECT DEFIBRILLATION ELECTRODES ON A LIFEPAK 20E FOR ONE HOUR SUCCESSFULLY. AN HOUR INTO IT, THE PAD REGISTERED AS A TEST PLUG (PER CUSTOMER, TO REGISTER FOR A TEST PLUG, THE PAD HAD TO HAVE 5OHM RESISTANCE). THEY THEN UNPLUGGED THE DEFIBRILLATION ELECTRODES FROM THE DEFIBRILLATOR AND BROUGHT ANOTHER DEFIBRILLATOR, ANOTHER LIKEPACK 20E BUT IT ALSO REGISTERED THE DEFIBRILLATION ELECTRODE AS A TEST PLUG ON THAT MACHINE TOO. THIS OCCURRED WITH JUST ONE PAD. WHEN THE PAD WAS REMOVED, THE PATIENT'S SKIN WAS RED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE PADS WERE ON THE PATIENT FOR APPROXIMATELY ONE HOUR MONITORING DURING A PROCEDURE WHILST THE PATIENT WAS UNDER GENERAL ANESTHETIC. THEY DID NOT TRY TO SHOCK THE PATIENT, THEY WERE JUST MONITORING WHEN ALL OF THE SUDDEN THE PAD REGISTERED AS A TEST PLUG. THEY CHANGED THE MACHINES AND TRIED THE SAME PAD ON THE PATIENT WITH ANOTHER LIKEPAK 20E AND THE SAME THING HAPPENED. THEY DID NOT NEED TO CHANGE THE PAD AS THE PROCEDURE FINISHED AND THERE WAS NO R

  Patient problems: Skin Irritation

  MAUDE report 9912338 ↗
• MalfunctionMar 30, 2020Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE GEL PEELED OFF OF THE DEFIB PAD WHEN THE BACKING SHEET WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898107 ↗
• MalfunctionMar 30, 2020Material Separation; Material Separation

  THE CARDINAL HEALTH SALES REPRESENTATIVE REPORTED THAT WHEN CHECKING HER INVENTORY OF MEDI-TRACE CADENCE PRE-CONNECT DEFIBRILLATION ELECTRODES, SHE FOUND THAT WHEN PEELING OFF THE BACKING SHEET OF THE PAD, THE GEL COMES AWAY.

  Patient problems: No Patient Involvement

  MAUDE report 9897200 ↗
• MalfunctionMar 23, 2020Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT WHEN THE PLASTIC BACKING IS PEELED OFF OF THE PAD, THE GEL IS PULLING OFF ONTO THE PLASTIC BACKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9867041 ↗
• MalfunctionJul 13, 2018Signal Artifact/Noise; Electrical /Electronic Property Problem; Signal Artifact/Noise

  THE ELECTRODE IS NOT WORKING DURING A PLANNED PROCEDURE (CARDIOVERSION).

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7685681 ↗
• MalfunctionFeb 20, 2018Gel Leak; Gel Leak

  THE CUSTOMER REPORTED THE GEL ON THE PAD HAS COME AWAY FROM THE PAD ITSELF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7282267 ↗