LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99402 (REF 99402-000016)Recalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 00883873813744), received between Dec 13, 2018 and Jan 6, 2026 — classified as 4 deaths, 169 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (71 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 173 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Device Sensing Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE PROMPTED A CONNECTION ISSUE WITH THE HANDLES. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975099 ↗
• MalfunctionAug 21, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN ITS MEMORY THAT IS INDICATIVE OF A DEVICE FAILURE WHICH COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM. THE DEFIBRILLATOR OUTPUT ENERGY COULD BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22869281 ↗
• MalfunctionMay 14, 2025Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT RECOGNIZE WHEN THE THERAPY CABLE IS PLUGGED IN. 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 22019145 ↗
• MalfunctionApr 11, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT ON BUTTON ON THEIR DEVICE IS NOT LONGER WORKING. 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 19087362 ↗
• MalfunctionMar 23, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO POWER ON. 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 18965540 ↗
• MalfunctionDec 21, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO PROVIDE DEFIBRILLATION ENERGY. THE SHOCK WAS PRODUCED WITH A DELAY. 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 18380210 ↗
• MalfunctionJul 11, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWER OFF AND CONTINUOUSLY RESTARTED. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981178 ↗
• MalfunctionJun 9, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645099 ↗
• MalfunctionJun 5, 2022Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WHEN POWERED ON WAS UNABLE TO SENSE THE CONNECTION OF THE DEFIBRILLATION THERAPY CABLE. THE CUSTOMER ADVISED THAT THE DEVICE PROMPTED THEM TO ¿CONNECT CABLE¿, THE DEFIBRILLATION PADS WERE ALREADY CONNECTED. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599426 ↗
• MalfunctionFeb 15, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535562 ↗
• MalfunctionOct 6, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  PHYSIO-CONTROL RECEIVED A REPORT FROM A CUSTOMER OF ALLEGED DEVICE MALFUNCTION, "DURING A CODE CALL, THE LP20 [LIFEPAK® 20 DEFIBRILLATOR/MONITOR] FAILED TO DELIVER A SHOCK. THE STAFF INITIALLY HAD PHILIPS PADS ON THE UNIT, UPON DISCOVERY THEY WENT AND CHANGED THE PADS OUT AND HOOKED UP STRYKER BRAND PADS TO THE UNIT. WHEN GOING TO GIVE A SHOCK THE UNIT FAILED TO DELIVER ONE." THE PHILIPS PADS USED ARE NOT APPROVED FOR USE WITH THIS DEFIBRILLATOR/MONITOR. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. THE CUSTOMER SWAPPED OUT THE UNIT FOR ANOTHER MONITOR/DEFIBRILLATOR AND SUCCESSFULLY DELIVERED A SHOCK.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586248 ↗
• MalfunctionJul 30, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WILL NOT POWER ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257006 ↗
• MalfunctionJun 24, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULDN'T DISCHARGE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER NO HEALTH CONSEQUENCES OR IMPACT WAS REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 12058339 ↗
• MalfunctionJun 7, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAS A BROKEN POWER BUTTON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946315 ↗
• MalfunctionApr 13, 2021Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO SENSE, STATING "UNIT WAS CHARGED FOR SHOCK DELIVERY WHEN THE DEVICE GAVE 'CONNECTORS NOT CONNECTED' WARNING. THIS OCCURRED 3 TIMES, SO ANOTHER UNIT WAS BROUGHT IN AND USED SUCCESSFULLY." THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. THE CUSTOMER CONFIRMED THAT THE DEVICE USE DID NOT CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

  Patient problems: Cardiac Arrest

  MAUDE report 11660587 ↗
• MalfunctionMar 31, 2021Unexpected Shutdown; Unexpected Shutdown

  A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ILLUMINATED ITS SERVICE LED AND POWERED OFF UNEXPECTEDLY DURING USE. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599506 ↗
• MalfunctionMar 29, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS UNEXPECTEDLY RESETTING ITSELF DURING TESTING. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR 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 11580954 ↗
• MalfunctionMar 25, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A THIRD PARTY SERVICE AGENT CONTACTED PHYSIO-CONTROL TO REPORT THAT ALL OF THE CUSTOMER DEVICE'S LIGHTS ARE ILLUMINATED AND WHEN THE DEVICE IS POWERED ON, IT DOES NOT PASS THE BOOT UP SCREEN. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568950 ↗
• MalfunctionDec 14, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WHEN POWERED ON WILL NOT GET OUT OF BOOT UP AND IS FLASHING LIGHTS. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004887 ↗
• MalfunctionDec 9, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED A WHITE SCREEN. THIS IS AN INDICATION THAT THE DEVICE MAY BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979718 ↗
• MalfunctionDec 8, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS DISPLAYING A WHITE SCREEN. A WHITE DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10970739 ↗
• MalfunctionDec 1, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE THE BOOT UP PROCESS. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928227 ↗
• MalfunctionNov 10, 2020Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING TESTING, THEIR DEVICE WAS UNABLE TO DETECT THE CONNECTION OF THE DEFIBRILLATION HARD PADDLES. THE CUSTOMER ADVISED THAT THE DEVICE WAS IN MANUAL MODE AND PROMPTED THEM TO ¿CONNECT CABLE¿. A NEW DEFIBRILLATION HARD PADDLES WAS TRIED BUT THE SAME ISSUE WAS OBSERVED. THE DEVICE WAS ABLE TO OPERATE PROPERLY WITH THE DEFIBRILLATION THERAPY CABLE. IN THIS STATE DEFIBRILLATION THERAPY WOULD BE DELAYED OR UNAVAILABLE IF NEEDED. THERE WAS NO PATIENT USE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10819665 ↗
• MalfunctionNov 10, 2020Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE POWER BUTTON ON THEIR DEVICE WAS NOT FUNCTIONING. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10817521 ↗
• MalfunctionNov 4, 2020Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A CRACKED SCREEN AND A WHITE DISPLAY. A WHITE DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10788567 ↗

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-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-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-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-0305-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
• Z-0299-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
• Z-0304-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
• Z-0302-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
• Z-0301-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
• Z-0303-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
• Z-0297-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
• Z-0296-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051

…and 2 more.