EDGE SYSTEM 11996 (REF 11996-000091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00883873784945), received between Nov 5, 2020 and May 19, 2026 — classified as 1 death, 20 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• DeathMay 19, 2026Patient Device Interaction Problem

  A customer contacted Stryker to report that their electrodes did not adhere properly to the patient and that the adhesive was weak. As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221403 ↗
• MalfunctionMay 18, 2026

  DURING CARDIOVERSION PATIENT SUSTAINED A MINOR BURN BELIEVED TO BE ATTRIBUTED TO THE LIFEPAC (QUIK-COMBO) EQUIPMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 25209332 ↗
• MalfunctionMay 11, 2026

  PATIENT SUSTAINED SUPERFICIAL SKIN BURN TO CHEST AFTER CARDIOVERSION USING QUICK-COMBO DEFIBRILLATOR PADS AND LIFEPAK DEVICE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 25139083 ↗
• MalfunctionApr 29, 2026Patient Device Interaction Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEFIBRILLATION ELECTRODES DID NOT ADHERE PROPERLY TO THE PATIENT AND THAT THE ADHESIVE WAS WEAK. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027300 ↗
• MalfunctionJan 31, 2024Arcing of Electrodes; Arcing of Electrodes

  THE CUSTOMER CONTACTED STRYKER TO REPORT "A POP AND SMALL PUFF OF SMOKE" WHILE IN USE WITH A PATIENT. THIS COULD PREVENT OR DELAY DEFIBRILLATION. THERE WAS NO ADVERSE EVENT REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619769 ↗
• MalfunctionDec 21, 2022Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODES FAILED TO DETECT A RHYTHM. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16026102 ↗
• MalfunctionDec 19, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODES FAILED TO CHARGE OR PROVIDE DEFIBRILLATION. THIS ISSUE IS PATIENT-RELATED AND A SIGNIFICANT DELAY IN THERAPY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010206 ↗
• MalfunctionAug 11, 2022Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION ELECTRODES DID NOT CONNECT TO THEIR DEVICE AS EXPECTED. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212354 ↗
• MalfunctionJul 28, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED AN ELECTRODE WITH DELAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124625 ↗
• MalfunctionApr 15, 2022Defective Component; Defective Component

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION ELECTRODES WERE UNABLE TO ADHERE TO THE PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. 10 PACKETS OF ELECTRODES WERE OPENED AND FOUND AFFECTED DURING REPORTED EVENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120873 ↗
• MalfunctionApr 12, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION ELECTRODES WERE UNABLE TO ADHERE TO THE PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14090595 ↗
• MalfunctionApr 12, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION ELECTRODES WERE UNABLE TO ADHERE TO THE PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14090352 ↗
• MalfunctionMar 25, 2022Device Sensing Problem; Device Sensing Problem

  STRYKER WAS NOTIFIED THAT THE CUSTOMER SUBMITTED A VOLUNTARY MEDWATCH REPORT (REFERENCE REPORT NUMBER MW5107075). THE FOLLOWING WAS REPORTED: "DEFIBRILLATOR PADS WERE APPLIED TO PATIENT AND WERE GOING TO BE USED AS INITIAL ASSESSMENT OF RHYTHM; HOWEVER, PADS DID NOT PICK UP RHYTHM. 2 SETS OF DEFIBRILLATOR PADS DID NOT FUNCTION CORRECTLY." THIS MDR IS FOR THE SECOND ELECTRODES USED. THE MEDWATCH REPORT FROM THE CUSTOMER INDICATES INTERVENTION WAS REQUIRED. HOWEVER, THE DESCRIPTION OF EVENT HAS NO EVIDENCE OF AN ADVERSE PATIENT OUTCOME.

  Patient problems: Asystole; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13897363 ↗
• MalfunctionMar 25, 2022Device Sensing Problem; Device Sensing Problem

  STRYKER WAS NOTIFIED THAT THE CUSTOMER SUBMITTED A VOLUNTARY MEDWATCH REPORT (REFERENCE REPORT NUMBER MW5107075). THE FOLLOWING WAS REPORTED: "DEFIBRILLATOR PADS WERE APPLIED TO PATIENT AND WERE GOING TO BE USED AS INITIAL ASSESSMENT OF RHYTHM; HOWEVER, PADS DID NOT PICK UP RHYTHM. 2 SETS OF DEFIBRILLATOR PADS DID NOT FUNCTION CORRECTLY." THIS MDR IS FOR THE FIRST ELECTRODES USED. THE MEDWATCH REPORT FROM THE CUSTOMER INDICATES INTERVENTION WAS REQUIRED. HOWEVER, THE DESCRIPTION OF EVENT HAS NO EVIDENCE OF AN ADVERSE PATIENT OUTCOME.

  Patient problems: Asystole; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13897360 ↗
• MalfunctionOct 21, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO DELIVER SHOCK WHILE IN USE WITH A PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: Burn(s); Ventricular Fibrillation

  MAUDE report 12677592 ↗
• MalfunctionSep 3, 2021Failure to Sense; Failure to Sense

  A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT DISPLAY ECG RHYTHM WHEN CONNECTED TO A PATIENT. AS A RESULT, DEVICE THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425401 ↗
• MalfunctionMar 26, 2021Failure to Sense; Failure to Sense

  A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEFIBRILLATION ELECTRODES DID NOT WORK DURING INTERVENTION ON A PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576247 ↗
• MalfunctionNov 10, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT SENSE RHYTHM OR HEART RATE WHILE QUIK-COMBO ELECTRODES WERE IN USE. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10818085 ↗
• MalfunctionNov 5, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THERAPY ELECTRODES ON THEIR DEVICE WERE NOT WORKING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10792561 ↗
• MalfunctionNov 5, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THERAPY ELECTRODES ON THEIR DEVICE WERE NOT WORKING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10792556 ↗
• MalfunctionNov 5, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THERAPY ELECTRODES ON THEIR DEVICE WERE NOT WORKING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10792555 ↗