LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 273 adverse event reports that list this exact device (DI 00883873911648), received between Apr 20, 2018 and Aug 21, 2026 — classified as 4 deaths, 1 injury, 268 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (102 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Aug 30, 2024Class IIOpen, Classified

   Due to an out of tolerance tool being used on monitor/defibrillator systems.

   Z-0230-2025 · Root cause: Vendor change control · Recall details · FDA record ↗

2. Sep 29, 2023Class IIOpen, Classified

   Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

   Z-0299-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 273 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Defibrillation/Stimulation Problem; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383294 ↗
• MalfunctionAug 12, 2026Unexpected Shutdown

  The customer contacted Stryker to report their device powers off with fully charged batteries. 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 50218819 ↗
• MalfunctionApr 13, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHUTTING DOWN DURING SELF TEST. 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 24867331 ↗
• MalfunctionApr 8, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHUT DOWN UNEXPECTEDLY. 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 24815551 ↗
• MalfunctionMar 17, 2026Failure to Deliver Shock/Stimulation; Unexpected Shutdown

  A CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, IT WAS OBSERVED BY THE SERVICE TECHNICIAN THAT THE DEVICE HAD UNEXPECTEDLY LOST POWER. ADDITIONALLY, IT WAS OBSERVED THAT THE DEVICE LOGGED AN EVENT CODE IN THE DEVICE'S MEMORY THAT IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622141 ↗
• MalfunctionDec 17, 2025Unexpected Shutdown; Unexpected Shutdown

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWERED OFF UNEXPECTEDLY. 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 23831474 ↗
• MalfunctionDec 17, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  DURING SERVICE OF DEVICE IT WAS OBSERVED THAT THE MAIN KEYPAD DOES NOT WORK. 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 23825620 ↗
• MalfunctionNov 20, 2025Fracture; Unexpected Shutdown; Fracture; Unexpected Shutdown

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD POWER OFF IMMEDIATELY AFTER 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 23603238 ↗
• MalfunctionNov 20, 2025Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH INDICATES THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602730 ↗
• MalfunctionOct 28, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD UNEXPECTEDLY LOST POWER. 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 23401280 ↗
• MalfunctionSep 17, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE EXPERIENCED AN UNEXPECTED LOSS OF POWER. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080260 ↗
• MalfunctionJul 28, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHUTTING DOWN UNEXPECTEDLY. 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 22639976 ↗
• MalfunctionJul 22, 2025Intermittent Loss of Power; Unexpected Shutdown; Intermittent Loss of Power; Unexpected Shutdown

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHUT DOWN WHILE IN USE. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF IT WAS NEEDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563280 ↗
• MalfunctionApr 23, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S MAIN KEYPAD DOES NOT WORK. 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 21894741 ↗
• MalfunctionFeb 13, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT OFF. 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 21375822 ↗
• MalfunctionJan 7, 2025Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEFIBRILLATION CHARGE ON THEIR DEVICE WAS INCOMPLETE. 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 21094360 ↗
• MalfunctionJan 7, 2025Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S PADDLES LEAD WOULD NOT PROVIDE ECG INFORMATION. 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 21092992 ↗
• MalfunctionDec 26, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD UNEXPECTEDLY LOST POWER. 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 21020645 ↗
• MalfunctionDec 17, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES 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 20953940 ↗
• MalfunctionOct 23, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE REPEATEDLY POWERED OFF DURING A PATIENT EVENT. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20512753 ↗
• MalfunctionJul 1, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING TESTING, THE STRYKER TECHNICIAN STATED THE DEVICE DEFIBRILLATION ENERGY CHARGED TO AN INCORRECT LEVEL. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645300 ↗
• MalfunctionJun 19, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAS UNEXPECTEDLY GONE BLANK INTERMITTENTLY. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568576 ↗
• MalfunctionMay 29, 2024Fracture; Fracture

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S THERAPY CABLE CONNECTOR IS BROKEN. IN THIS STATE DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19416692 ↗
• MalfunctionApr 15, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS UNEXPECTEDLY POWERING OFF. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104987 ↗
• MalfunctionApr 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104077 ↗