EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector 11996Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00721902195037), received between Mar 6, 2020 and Sep 14, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2021Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THEY RECEIVED A REPORT OF DELAMINATION FROM THE FIELD ON PM20003.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470273 ↗
• MalfunctionAug 31, 2021Peeled/Delaminated; Peeled/Delaminated

  CUSTOMER OF STRYKER (B)(6) COMPLAINED OF DELAMINATION OF THE ELECTRODE.

  Patient problems: Insufficient Information

  MAUDE report 12392778 ↗
• MalfunctionJun 18, 2021Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THEY WERE CONTACTED ABOUT AN END USER THAT FOUND THE GEL IS TEARING AWAY FROM THE ELECTRODE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025014 ↗
• MalfunctionJun 1, 2021Peeled/Delaminated; Peeled/Delaminated

  CUSTOMER REPORTS THAT ONE OF THEIR CUSTOMERS REPORTED THAT AN ELECTRODE WAS FOUND TO BE EXPERIENCING ADHESIVE/GEL DAMAGE WHEN THE PAD WAS PEELED.

  Patient problems: Insufficient Information

  MAUDE report 11913339 ↗
• MalfunctionJul 14, 2020Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE GEL WAS DELAMINATING FROM THE ELECTRODE. WHEN THE LINER WAS PEELED OFF THE GEL WAS REMOVED OFF WITH THE LINER. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 10272639 ↗
• MalfunctionMar 6, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THEIR DEVICE ON A PATIENT AND THE DEFIBRILLATION ELECTRODES WERE NOT WORKING CORRECTLY AND FAILED TO PICK UP AN ECG RHYTHM THROUGH THE PADDLES LEAD. ANOTHER SET OF DEFIBRILLATION ELECTRODES WERE OBTAINED AND THESE ALSO FAILED TO PICK UP THE PATIENT'S ECG RHYTHM THROUGH THE PADDLES LEAD. THE LAST SET OF DEFIBRILLATION ELECTRODES WERE OBTAINED AND WORKED NORMALLY AND THE USERS WERE ABLE TO MONITOR THE PATIENT AND CONTINUE PATIENT CARE. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9803189 ↗
• MalfunctionMar 6, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THEIR DEVICE ON A PATIENT AND THE DEFIBRILLATION ELECTRODES WERE NOT WORKING CORRECTLY AND FAILED TO PICK UP AN ECG RHYTHM THROUGH THE PADDLES LEAD. ANOTHER SET OF DEFIBRILLATION ELECTRODES WERE OBTAINED AND THESE ALSO FAILED TO PICK UP THE PATIENT'S ECG RHYTHM THROUGH THE PADDLES LEAD. THE LAST SET OF DEFIBRILLATION ELECTRODES WERE OBTAINED AND WORKED NORMALLY AND THE USERS WERE ABLE TO MONITOR THE PATIENT AND CONTINUE PATIENT CARE. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9803188 ↗