LIFEPAK 15 monitor/defibrillator 97577 (REF 99577-001957U)Recalls & reported problems

Physio-Control, Inc. · 15AACBABBABBBAAAAAAAAABFLP15 MONITOR/DEFIB · Class 3

All models of LIFEPAK 15 monitor/defibrillator (93)

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00883873793749), received between Jun 7, 2021 and Mar 15, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (2 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

Unexpected Shutdown2
Device Sensing Problem1
Failure to Power Up1

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 15, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN WHEN 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 18910578 ↗
MalfunctionOct 11, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17910136 ↗
MalfunctionSep 18, 2023Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT SHOW THE THERAPY CABLE ON THE SCREEN. IN THIS STATE DEFIBRILLATION THERAPY WOULD BE DELAYED OR UNAVAILABLE 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 17764023 ↗
MalfunctionJun 7, 2021Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUTS DOWN. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11946313 ↗

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-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
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-0305-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
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-0299-2024 · Sep 29, 2023 · Open, Classified
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602

…and 2 more.

Device details

UDI-DI	`00883873793749`
Brand	LIFEPAK 15 monitor/defibrillator
Model	97577
Catalog no.	99577-001957U
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	Aug 8, 2023

Device type (GMDN): Physiologic-monitoring defibrillation system

An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.

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All Automated external defibrillators (non-wearable) devices →

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.

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