EDGE SYSTEMRecalls & reported problems across all models

We found 4 models of EDGE SYSTEM by Physio-Control, Inc. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2020 and Aug 21, 2026 — classified as 1 death, 2 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EDGE SYSTEM problems

EDGE SYSTEM models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EDGE SYSTEM 11996

  Automated external defibrillators (non-wearable)
  35 reports
• EDGE SYSTEM 11996

  Automated external defibrillators (non-wearable)
  1 death21 reports
• EDGE SYSTEM 11996

  Automated external defibrillators (non-wearable)
  16 reports
• EDGE SYSTEM 11996

  Automated external defibrillators (non-wearable)
  9 reports

Recent EDGE SYSTEM adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 23, 2026Patient Device Interaction Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEFIBRILLATION PADS ON THEIR DEVICE DID NOT ATTACH TO THE PATIENT. THIS ISSUE MAY PREVENT THE DEVICE FROM PROVIDING 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 25596146 ↗
• 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 ↗
• 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 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 ↗
• 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 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 ↗
• 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 ↗
• 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 19, 2026Device Sensing Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEY WERE UNABLE TO CONNECT THE DEFIBRILLATION ELECTRODES TO THEIR DEVICE WHEN ATTEMPTED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387582 ↗
• 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 ↗

Other Physio-Control, Inc. products

• LIFEPAK 15 monitor/defibrillator93 models · 4,675 reports · 12 recalls
• LIFEPAK CR28 models · 2,307 reports
• LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors23 models · 1,382 reports · 1 recall
• LIFEPAK CR Plus and LIFEPAK Express defibrillators25 models · 396 reports
• LIFEPAK 1000 defibrillator5 models · 279 reports · 1 recall
• LIFEPAK2 models · 57 reports · 1 recall
• LIFEPAK 12 defibrillator/monitor19 models · 71 reports