LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507 (REF 99507-000122)Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00883873853863), received between Mar 27, 2018 and Mar 6, 2025 — classified as 3 deaths, 75 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (30 reports).

17 other recalls cover devices cleared under the same FDA submission (P160026); they may or may not involve this specific model.

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 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE CANNOT BE POWERED ON. 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 21537051 ↗
• MalfunctionJul 11, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON VIA AC POWER. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19717860 ↗
• MalfunctionJun 21, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DELIVER DEFIBRILLATION 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 19582358 ↗
• MalfunctionJun 4, 2024Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT RECOGNIZE DEFIBRILLATION PADDLES. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461167 ↗
• MalfunctionMay 30, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD A COMPLETELY WHITE DISPLAY. A WHITE DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19423648 ↗
• MalfunctionMar 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837780 ↗
• MalfunctionJan 17, 2024Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE WAS HAVING A CONNECTION PROBLEM BETWEEN THE DEVICE AND THE DEFIBRILLATION ELECTRODES. THE CUSTOMER ADVISED THAT THE DEVICE LOST CONTACT WITH THE PATIENT. THEY ALSO ADVISED THE DEVICE PROMPTED "CONNECT ELECTRODES". IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THE PATIENT DID NOT SURVIVE. HOWEVER THE CUSTOMER ADVISED THAT THE PATIENT WAS IN ASYSTOLE UPON ARRIVAL TO THE ER AND NEVER REGAINED ROSC.

  Patient problems: Asystole

  MAUDE report 18530891 ↗
• MalfunctionJan 10, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYS A WHITE SCREEN. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482041 ↗
• MalfunctionDec 5, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOCKED UP AND GAVE A BLANK SCREEN. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268522 ↗
• MalfunctionDec 4, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD ILLUMINATED ITS SERVICE LED AND WOULD GET STUCK IN THE INITIAL BOOT UP CYCLE. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264183 ↗
• MalfunctionNov 16, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE¿S DISPLAY IS WHITE. A WHITE DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156601 ↗
• MalfunctionNov 10, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT DEFIBRILLATION ENERGY DELIVERY LEVEL ON THEIR DEVICE IS NOT AS EXPECTED AND THAT THE DEVICE FAILED TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110497 ↗
• MalfunctionNov 10, 2023Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110295 ↗
• DeathAug 30, 2023Failure to Deliver Energy; Failure to Deliver Energy

  STRYKER WAS NOTIFIED THAT THE CUSTOMER SUBMITTED A VOLUNTARY MEDWATCH (MEDSUN) FORM. MEDWATCH REFERENCE REPORT NUMBER IS UNKNOWN. THE FOLLOWING WAS REPORTED BY THE CUSTOMER: "THE PATIENT WENT INTO CARDIOPULMONARY ARREST ON (B)(6) 2023 AT APPROX. 19:00. CPR WAS INITIATED AND THE LIFEPAK 20E DEFIBRILLATOR WAS ATTACHED. HE WAS FOUND TO BE IN PULSELESS / VF. THERE WAS AN UNFORESEEABLE MALFUNCTIONING WITH THE PATIENT'S BEDSIDE LIFEPAK 20E WHICH RESULTED IN NO DEFIBRILLATION BEING RECEIVED. DESPITE THE LIFEPAK 20E APPEARING FUNCTIONAL AND SHOWING THE DYSRHYTHMIA, IT DID NOT DISCHARGE. ULTIMATELY, PATIENT MISSED THE FIRST TWO REQUIRED DEFIBRILLATIONS IN ACCORDANCE WITH ACLS PROTOCOL DUE TO THIS MALFUNCTIONING. A NEW LIFEPAK 20E WAS OBTAINED, AND PATIENT'S FIRST DEFIBRILLATION WAS RECORDED AT 19:12. PATIENT RECEIVED MAXIMAL THERAPY INCLUDING MULTIPLE DEFIBRILLATIONS AND OTHER MEDICATIONS. WHILE ARRANGING TRANSFER TO ICU, PATIENT AGAIN WENT INTO PULSELESS VT. ACLS PROTOCOL WAS RESUMED. FAMILY WISHED TO CEASE RESUSCITATIVE EFFORTS. PATIENT DEATH PRONOUNCED AT 19:43."

  Patient problems: Cardiac Arrest

  MAUDE report 17656771 ↗
• MalfunctionAug 30, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THEIR DEVICE DISPLAYED A BLANK SCREEN. THIS CAN BE INDICATIVE OF A DEVICE LOCK-UP. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17648940 ↗
• MalfunctionAug 23, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE PADS WERE ARCING AND CAUGHT FIRE DURING PATIENT CARE. AS A RESULT, DEFIBRILLATION 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 17602525 ↗
• MalfunctionJun 22, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DELIVER DEFIBRILLATION THERAPY. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THE CUSTOMER ADVISED THAT ANOTHER DEFIBRILLATOR WAS ATTEMPTED TO BE USED, HOWEVER, THE PATIENT'S HEART RHYTHM CONVERTED IN ROUTE. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180390 ↗
• MalfunctionMay 5, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT POWER ON. 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 16875817 ↗
• MalfunctionMay 5, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT POWER ON. 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 16875696 ↗
• MalfunctionApr 25, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811442 ↗
• MalfunctionApr 25, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE INTERMITTENTLY DID NOT POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811439 ↗
• MalfunctionJan 30, 2023Failure to Power Up; Defibrillation/Stimulation Problem; Failure to Power Up; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO PROVIDE DEFIBRILLATION THERAPY. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264708 ↗
• MalfunctionNov 4, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S ON BUTTON IS NOT RESPONSIVE. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731818 ↗
• DeathOct 5, 2022Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEY WERE USING THEIR DEVICE DURING A PATIENT EVENT AND THE ATTEMPTED TO CHARGE THE DEVICE TO DELIVER DEFIBRILLATION THERAPY; HOWEVER, THE DEVICE FAILED TO CHARGE. THE USERS ATTEMPTED TO CHARGE THE DEVICE AGAIN AND THIS TIME IT WORKED AND THEY WERE ABLE TO DELIVER MULTIPLE SHOCKS TO THE PATIENT. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

  Patient problems: Chest Pain

  MAUDE report 15543667 ↗
• MalfunctionOct 5, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT COMPLETING ITS BOOT UP CYCLE UPON POWERING ON. 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 15543620 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160026. One submission often covers many models, so check the product and lot details in each record.

• Z-2065-2026 · Apr 13, 2026 · Open, Classified
  LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001
• Z-2498-2025 · Jul 22, 2025 · Open, Classified
  LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953
• Z-2497-2025 · Jul 22, 2025 · Open, Classified
  LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V
• Z-1232-2025 · Feb 3, 2025 · Open, Classified
  LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
• Z-1184-2025 · Jan 21, 2025 · Open, Classified
  LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo LNCS-II rainbow DCI 8 SpCO, Adult Reusable Sen
• Z-0230-2025 · Aug 30, 2024 · Open, Classified
  LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99
• Z-0567-2024 · Nov 6, 2023 · Open, Classified
  AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
• Z-0304-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
• Z-0305-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
• Z-0303-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
• Z-0298-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
• Z-0296-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
• Z-0301-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
• Z-0300-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
• Z-0297-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061

…and 2 more.