EDGE System™ Electrodes with QUIK-COMBO Connector 11996Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00721902195075), received between May 20, 2022 and Aug 1, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED AN ELECTRODE WITH DELAMINATION. PER CUSTOMER, GEL CAME OFF THE PAD AND ONTO THE PATIENT SKIN. THE CUSTOMER FURTHER STATED THAT THE PATIENT WAS SUCCESSFULLY CARDIOVERTED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138105 ↗
• MalfunctionJul 29, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED AN ELECTRODE WITH DELAMINATION. PER CUSTOMER, GEL CAME OFF THE PAD AND ONTO THE PATIENT SKIN. THE CUSTOMER FURTHER STATED THAT THE PATIENT WAS SUCCESSFULLY CARDIOVERTED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15134947 ↗
• MalfunctionJul 29, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED AN ELECTRODE WITH DELAMINATION. PER CUSTOMER, GEL CAME OFF THE PAD AND ONTO THE PATIENT SKIN. THE CUSTOMER FURTHER STATED THAT THE PATIENT WAS SUCCESSFULLY CARDIOVERTED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15134132 ↗
• MalfunctionJul 29, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED AN ELECTRODE WITH DELAMINATION. PER CUSTOMER, GEL CAME OFF THE PAD AND ONTO THE PATIENT SKIN. THE CUSTOMER FURTHER STATED THAT THE PATIENT WAS SUCCESSFULLY CARDIOVERTED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15133429 ↗
• MalfunctionJul 29, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED AN ELECTRODE WITH DELAMINATION. PER CUSTOMER, GEL CAME OFF THE PAD AND ONTO THE PATIENT SKIN. THE CUSTOMER FURTHER STATED THAT THE PATIENT WAS SUCCESSFULLY CARDIOVERTED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15133120 ↗
• MalfunctionJul 29, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED AN ELECTRODE WITH DELAMINATION. PER CUSTOMER, GEL CAME OFF THE PAD AND ONTO THE PATIENT SKIN. THE CUSTOMER FURTHER STATED THAT THE PATIENT WAS SUCCESSFULLY CARDIOVERTED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15132193 ↗
• MalfunctionMay 20, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE CARDIAC NURSE PRACTITIONER OBSERVED THE GEL COMING AWAY FROM THE DEFIB PAD WITH THE SECTION THAT IS PEELED OFF. THIS INCIDENT OCCURRED THE WEEK PRIOR ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463492 ↗
• MalfunctionMay 20, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING ELECTIVE CARDIOVERSION, THE CARDIAC NURSE PRACTITIONER OBSERVED THE GEL COMING AWAY FROM THE DEFIB PAD WITH THE SECTION THAT IS PEELED OFF. THE EXPIRATION DATE HAD NOT LAPSED AS IT WAS SEPTEMBER 2022. THE SAME PRODUCT AND LOT NUMBER WAS USED AS A REPLACEMENT AND WAS INTACT. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463410 ↗