LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403 (REF 99403-000157)Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00883873820568), received between Dec 13, 2018 and Aug 17, 2026 — classified as 1 death, 117 malfunctions.

The most frequently reported specific device problem is “Power Problem” (45 reports).

1 other recall cover devices cleared under the same FDA submission (P160012); 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 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Failure to Power Up

  The customer contacted Stryker to report that their device would not power on with a new battery. 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 50275963 ↗
• MalfunctionMar 4, 2026Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT RECOGNIZE THE PADS CONNECTED ON A PATIENT. 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 24510761 ↗
• MalfunctionFeb 10, 2026Failure 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 24309764 ↗
• MalfunctionJun 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 WOULD 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 22294274 ↗
• MalfunctionJun 18, 2025Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYED ALL THREE ICONS (CHARGE-PAK, ATTENTION, AND SERVICE WRENCH). THE ILLUMINATION OF ALL THREE ICONS INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286976 ↗
• MalfunctionMar 28, 2025Power Problem; Power Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727176 ↗
• MalfunctionMar 4, 2025Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE'S BATTERY WAS LEFT OUTDOORS AND NOW THEIR DEVICE WILL NOT POWER ON. IN THIS STATE THE DEVICE WOULD 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 21512698 ↗
• MalfunctionOct 22, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S VOICE PROMPTS WERE INTERMITTENTLY NOT WORKING. WITHOUT VOICE PROMPTS, A USER MAY NOT RECEIVE THE GUIDANCE NECESSARY TO USE THE DEVICE TO DELIVER DEFIBRILLATION THERAPY TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503298 ↗
• MalfunctionOct 16, 2024No Audible Prompt/Feedback; Audible Prompt/Feedback Problem; No Audible Prompt/Feedback; Audible Prompt/Feedback Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD INTERMITTENTLY NOT EMIT AUDIO PROMPTS, DELAY VOICE PROMPTS OR SKIP STEPS WITHIN THE VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459621 ↗
• MalfunctionOct 2, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE VOICE PROMPTS CORRECTLY. IN THIS STATE DEFIBRILLATION THERAPY MAY BE DELAYED IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350927 ↗
• MalfunctionSep 25, 2024Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299323 ↗
• MalfunctionAug 22, 2024Failure to Power Up; Power Problem; Failure to Power Up; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL 3 ICONS (CHARGE-PAK, ATTENTION AND WRENCH) AND IT 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 20031951 ↗
• MalfunctionJul 1, 2024Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651993 ↗
• MalfunctionJun 28, 2024Power Problem; Power Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634822 ↗
• MalfunctionJun 20, 2024Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK, AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575068 ↗
• MalfunctionMay 14, 2024Power Problem; Audible Prompt/Feedback Problem; Power Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315886 ↗
• MalfunctionApr 15, 2024Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYED THE WRENCH, BATTERY, AND WARNING ICONS. WITH ALL 3 ICONS PRESENT (CHARGE-PAK, ATTENTION AND WRENCH) DEFIBRILLATION (AUTOMATED, MANUAL OR SYNCHRONIZED CARDIOVERSION) THERAPY MAY NOT BE ABLE TO BE DELIVERED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105339 ↗
• MalfunctionMar 6, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY STRYKER, THE DEVICE WOULD NOT DEFIBRILLATE. 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 18849793 ↗
• MalfunctionNov 27, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT AN UNEXPECTED LOSS OF POWER. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213332 ↗
• MalfunctionSep 26, 2023Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON, WHEN ATTEMPTED. AS A RESULT, 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 17815799 ↗
• MalfunctionSep 19, 2023Power Problem; Audible Prompt/Feedback Problem; Power Problem; Audible Prompt/Feedback Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE AUDIO VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774169 ↗
• MalfunctionAug 18, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573798 ↗
• MalfunctionAug 15, 2023Power Problem; Power Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549891 ↗
• MalfunctionMay 18, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE AUDIO VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953780 ↗
• MalfunctionApr 27, 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 16825050 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160012. One submission often covers many models, so check the product and lot details in each record.

• Z-1544-2026 · Jan 21, 2026 · Open, Classified
  PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682