LIFEPAK 1000 defibrillator 99425 (REF 99425-000023)Recalls & reported problems

Physio-Control, Inc. · LP1000 CONFIGURED UNIT1000AAAAAAAACABAAAAAAAAA · Class 3

All models of LIFEPAK 1000 defibrillator (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This LIFEPAK 1000 is a portable defibrillator that delivers electric shocks to a heart in cardiac arrest. Many of its 188 reports describe the unit failing to power up or shutting down, a connect electrodes message, or delayed shock charging. Many reports say no patient was involved. There are no injuries and 1 death report. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 188
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 00883873815458), received between Dec 17, 2018 and Aug 12, 2026 — classified as 1 death, 187 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (46 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Power Up46
Electrical /Electronic Property Problem25
Failure to Sense18
Unexpected Shutdown15
Failure to Deliver Shock/Stimulation13
Connection Problem11
Device Sensing Problem11
Failure to Charge10

Patient problems

No Clinical Signs, Symptoms or Conditions124
No Patient Involvement55
No Known Impact Or Consequence To Patient11
Cardiac Arrest3
Asystole1
Death1

Recent adverse event reports

The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 12, 2026Delayed Charge Time
During annual service Stryker observed that the device's defibrillation charge is delayed. In this state defibrillation therapy may be delayed or not be available if needed. There was no patient involvement reported with the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218756 ↗
MalfunctionAug 4, 2026Delayed Charge Time
During preventive maintenance, Stryker observed that the device will not pass the shock time limit test and that defibrillation charge is delayed. 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 50129281 ↗
MalfunctionFeb 19, 2026Failure to Power Up; Key or Button Unresponsive/not Working
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. FURTHERMORE, DURING EVALUATION IT WAS FOUND THAT THE ON BUTTON WOULD NOT RESPOND. 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 24392219 ↗
MalfunctionJan 27, 2026Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE CONTINUOUSLY GIVES THE "CONNECT ELECTRODES" MESSAGE WHEN ATTACHED TO A PATIENT. 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 24190837 ↗
MalfunctionJan 15, 2026Connection Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS GIVING A "CONNECT ELECTRODES" MESSAGE, EVEN THOUGH IT IS CONNECTED, 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 24080101 ↗
MalfunctionJun 25, 2025Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED THE IMPEDANCE TEST. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED, AS THE DEVICE WOULD NOT BE ABLE TO DETECT SHOCKABLE RHYTHM. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328703 ↗
MalfunctionMay 16, 2025Failure 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 IT WERE NEEDED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22037273 ↗
MalfunctionApr 22, 2025Power Problem; Power Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S BATTERY PORT IS DAMAGED. IN THIS STATE THE USER CANNOT INSERT THE BATTERY AND 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 21885873 ↗
MalfunctionMar 4, 2025Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE HAD AN LOGGED AN EVENT CODE THAT COULD POTENTIALLY INDICATES A DEVICE SENSING PROBLEM. 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 21512741 ↗
MalfunctionFeb 19, 2025Failure 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 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 21416905 ↗
MalfunctionDec 27, 2024Fracture; Fracture
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT HOLD THE BATTERY IN THE COMPARTMENT. 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 21026314 ↗
MalfunctionDec 19, 2024Failure to Power Up; Failure to Power Up
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION 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 20978718 ↗
MalfunctionOct 11, 2024Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE GAVE "CONNECT ELECTRODES" MESSAGE WHEN PADS WERE PLUGGED IN. 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 20426966 ↗
MalfunctionOct 7, 2024Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE UNEXPECTEDLY SHUTS OFF. 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 20391793 ↗
MalfunctionSep 16, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT SCREEN ON THEIR DEVICE IS NOT FUNCTIONAL. 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 20221886 ↗
MalfunctionSep 5, 2024Fracture; Fracture
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S BATTERY PINS WERE BROKEN. 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 20143090 ↗
MalfunctionAug 6, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER 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 19917014 ↗
MalfunctionJul 19, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DELIVER A SHOCK. 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 19780492 ↗
MalfunctionJul 15, 2024Failure to Power Up; Failure to Power Up
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION 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 19746883 ↗
MalfunctionJun 20, 2024Fracture; Fracture
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE BATTERY WOULD NOT INSERT INTO THE DEVICE. 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 19573455 ↗
MalfunctionMay 23, 2024Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE GAVE A "CONNECT ELECTRODES" ERROR. 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 19383328 ↗
MalfunctionMay 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS NOT WORKING. 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 19230747 ↗
MalfunctionApr 26, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD ILLUMINATED ITS SERVICE LED AND HAD DISPLAYED 'ABNORMAL ENERGY DELIVERY' MESSAGE. AS A RESULT, WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19198190 ↗
MalfunctionApr 11, 2024Failure 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 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 19085768 ↗
MalfunctionApr 10, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE WAS FAILING TO DELIVER A SHOCK DURING THE SELF TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19079460 ↗

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-0299-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Z-0301-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
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
Z-0302-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Z-0304-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Z-0303-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Z-0300-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002

…and 2 more.

Device details

UDI-DI	`00883873815458`
Brand	LIFEPAK 1000 defibrillator
Model	99425
Catalog no.	99425-000023
Company	Physio-Control, Inc.
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	P160026
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 18, 2020

Device type (GMDN): Non-rechargeable professional semi-automated external defibrillator

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, and to audibly/visually instruct an operator to enable it to activate defibrillation of the heart or allow the operator to decide when to activate defibrillation based on its electrocardiogram display. It is intended to be used by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and skin-adhesive electrodes to monitor the rhythm/deliver the shocks; it has internal non-rechargeable batteries that must be replaced when indicated.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page