Medi-Trace Cadence 22660RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884527022349), received between Jan 20, 2021 and Dec 14, 2021 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• DeathFeb 18, 2021Fire; Arcing; Fire; Arcing

  THE CUSTOMER REPORTED A FIRE DURING DEFIBRILLATION IN WHICH THE PATIENT SUSTAINED 2ND AND 3RD DEGREE BURNS TO THE RIGHT UPPER SHOULDER, RIGHT UPPER ARM, HEAD, AND FACIAL AREA. THE CUSTOMER FURTHER STATED THE PATIENT DEVELOPED AN EXTENSIVE LOWER GI BLEED. THE FACILITY ACTIVATED A CODE HEMORRHAGE AS THE PATIENT WAS HYPOTENSIVE. DURING THAT TIME THE PATIENT WENT INTO VTACH AND VFIB ARREST AND A CODE BLUE WAS CALLED CONCOMITANTLY WITH THE CODE HEMORRHAGE. THE PATIENT WAS DEFIBRILLATED FIVE TIMES. ON THE SIXTH TIME THERE WAS AN OBSERVABLE ARC/BRIGHT LIGHT SOMEWHERE BETWEEN THE DEFIBRILLATION ELECTRODE PAD, THE MONITORING PADS, AND THE EKG CABLES (FROM ANOTHER MANUFACTURER) IN THE AREA THAT EXTENDED TO THE PATIENT'S UPPER RIGHT SHOULDER AREA. IT QUICKLY WENT INTO A SPARK THEN FLAMES WHICH ENGULFED THE PATIENTS RIGHT UPPER SHOULDER, RIGHT UPPER ARM, HEAD, AND FACIAL AREA. THE FIRE WAS PUT OUT BY THE STAFF IN 3-6 SECONDS AND RESUSCITATION CONTINUED. THE PATIENT WAS REINTUBATED AND THE CODE CONTINUED FOR 40-45 MINUTES WITHOUT THE RETURN OF SPONTANEOUS CIRCULATION. THE PATIENT WAS PRONOUNCED EXPIRED. THE FACILITY DID HAVE PHOTOGRAPHS TAKEN OF THE SKIN IMPAIRMENT. THE FACILITY REFUSED TO PRO

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 11345724 ↗
• MalfunctionFeb 18, 2021Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT AFTER TESTING THE DEFIB PADS THEY NOTICED DISCOLORATION ON THE APEX SIDE. UPON REVIEW OF THE PHOTO THAT WAS PROVIDED BY THE CUSTOMER, ONE PAD HAD AN AREA OF GEL DELAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343128 ↗
• MalfunctionJan 20, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE CADENCE DEFIB PAD WAS UNABLE TO DELIVER A SHOCK TO A PATIENT REQUIRING DEFIBRILLATION DURING OPEN HEART SURGERY. A SHOCK WAS ABLE TO BE GENERATED USING INTERNAL PADDLES AND THE PATIENT RECOVERED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202222 ↗