EDGE SYSTEM 11996 (REF 11996-000017)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00883873784969), received between Apr 20, 2020 and Aug 21, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (15 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380792 ↗
• MalfunctionMay 22, 2026Device Sensing Problem

  The customer contacted Stryker to report that during a patient event the defibrillation electrodes intermittently was unable to detect the patient. When the electrode wires were manipulated, the connection resumed. In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253972 ↗
• MalfunctionMay 20, 2026Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT, WHEN CONNECTED, THE ELECTRODES DID NOT WORK. 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 25227718 ↗
• MalfunctionMay 20, 2026Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT, WHEN CONNECTED, THE ELECTRODES DID NOT WORK. 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 25227715 ↗
• MalfunctionMay 20, 2026Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT, WHEN CONNECTED, THE ELECTRODES DID NOT WORK. 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 25227714 ↗
• MalfunctionMay 19, 2026Device Sensing Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR ELECTRODES FAILED TO DETECT PATIENT DURING INTERVENTION. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE. THE HEALTH CARE PROVIDER CONFIRMED THAT THE DEVICE USE DID NOT CONTRIBUTED TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212983 ↗
• MalfunctionApr 30, 2026Failure to Sense

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODES WOULD NOT DISPLAY ANY SIGNAL WHEN CONNECTED. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045763 ↗
• MalfunctionMar 2, 2026Patient Device Interaction Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODES HAD VERY LOW ADHESIVENESS AND WOULD NOT STAY ATTACHED TO THE PATIENT'S SKIN. 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 24491621 ↗
• MalfunctionFeb 10, 2026Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE WAS UNABLE TO DETECT THE CONNECTION OF THE DEFIBRILLATION ELECTRODES. ANOTHER SET OF ELECTRODES WERE USED SUCCESSFULLY. 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 PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304948 ↗
• MalfunctionSep 9, 2025Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A DEFIBRILLATION ELECTRODE CONNECTOR PIN WAS BENT. THE BENT PIN PROHIBITED THE CONNECTION BETWEEN THE DEFIBRILLATOR AND THE DEFIBRILLATOR ELECTRODE. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002974 ↗
• MalfunctionApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SASKATCHEWAN HEALTH AUTHORITY CONTACTED STRYKER TO REPORT THAT A HOSPITAL REPORTED THE QUICK COMBO PADS BURNED A PATIENT'S CHEST.

  Patient problems: Burn(s)

  MAUDE report 21810814 ↗
• MalfunctionApr 9, 2025Failure to Deliver Energy; Failure to Deliver Energy

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION ELECTRODES FAILED TO PROVIDE ENERGY DURING INTERVENTION ON A PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21803771 ↗
• MalfunctionMar 10, 2025Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR QUICK-COMO CONNECTION WIRES WERE FRAYED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561461 ↗
• MalfunctionFeb 5, 2025Device Sensing Problem; Device Sensing Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION PADS COULD NOT DETECT PATIENT RHYTHM. 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 21317962 ↗
• MalfunctionFeb 5, 2025Device Sensing Problem; Device Sensing Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION PADS COULD NOT DETECT PATIENT RHYTHM. 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 21317960 ↗
• MalfunctionJan 29, 2025Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THEY FOUND A PACK OF PM20222, LOT 331026 TO CONTAIN ONE PAD INSTEAD OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264316 ↗
• MalfunctionApr 30, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODES OF THEIR DEVICE WOULD NOT DELIVER DEFIBRILLATION. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213191 ↗
• MalfunctionMay 25, 2023Failure to Sense; Failure to Sense

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODES OF THEIR DEVICE WOULD NOT DETECT THE PATIENT WHEN ATTACHED. THIS RESULTED IN A DELAY IN INTERVENTION FOR 20 MINUTES AND DEFIBRILLATION WOULD NOT BE AVAILABLE, WHEN 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 17001078 ↗
• MalfunctionJan 10, 2023Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR ELECTRODES DID NOT WORK AS EXPECTED. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THEY WERE ABLE TO OPEN TO SUCCESSFULLY USE ANOTHER SET OF ELECTRODES. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131185 ↗
• MalfunctionOct 17, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION PADS DID NOT DELIVER SHOCK ON TWO ATTEMPTS DURING PATIENT USE. THE CUSTOMER FURTHER ADVISED NEW LOT OF DEFIBRILLATION PADS WERE USED AND SHOCK SUCCESSFULLY DELIVERED TO PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619627 ↗
• MalfunctionOct 12, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION PADS DID NOT DELIVER SHOCK ON TWO ATTEMPTS DURING PATIENT USE. THE CUSTOMER FURTHER ADVISED NEW LOT OF DEFIBRILLATION PADS WERE USED AND SHOCK SUCCESSFULLY DELIVERED TO PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591453 ↗
• MalfunctionDec 17, 2021Failure to Sense; Failure to Sense

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT DETECT A PATIENT THROUGH DEFIBRILLATION ELECTRODES DURING A PATIENT EVENT. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13029347 ↗
• MalfunctionDec 16, 2021Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEY WERE USING THEIR DEVICE ON A PATIENT AND THE DEFIBRILLATION ELECTRODES FAILED TO PICK UP THE PATIENT'S ECG RHYTHM. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF NEEDED. A NEW SET OF DEFIBRILLATION ELECTRODES WERE USED TO CONTINUE PATIENT CARE. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022799 ↗
• MalfunctionDec 7, 2021Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT RECOGNIZE DEFIBRILLATION PADS WERE CONNECTED. THE CUSTOMER TESTED DEVICE AND BELIEVES THE DEFIBRILLATION ELECTRODES WERE THE ISSUE. IN THIS STATE THE DEVICE WOULD 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 12954929 ↗
• MalfunctionNov 10, 2021Failure to Sense; Failure to Sense

  A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT ELECTRODES FROM THEIR DEVICE FAILED TO SENSE PATIENT RHYTHM DURING INTERVENTION. 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 12790493 ↗