LIFEPAK CR Plus and LIFEPAK Express defibrillatorsRecalls & reported problems across all models
Physio-Control, Inc. · 25 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 396
- Deaths reported
- 5
- Injuries reported
- 0
- Recalls
- 0
We found 25 models of LIFEPAK CR Plus and LIFEPAK Express defibrillators by Physio-Control, Inc. in the FDA's device registry (GUDID). Together they are named in 396 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2018 and Aug 17, 2026 — classified as 5 deaths, 391 malfunctions.
The most frequently reported specific device problem is “Power Problem” (167 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LIFEPAK CR Plus and LIFEPAK Express defibrillators problems
Device problems
- Power Problem167
- Failure to Power Up122
- Electrical /Electronic Property Problem21
- Failure to Analyze Signal20
- No Audible Prompt/Feedback16
- Audible Prompt/Feedback Problem14
- Device Sensing Problem13
- Unexpected Shutdown12
Patient problems
- No Patient Involvement217
- No Clinical Signs, Symptoms or Conditions180
- Cardiac Arrest4
- No Known Impact Or Consequence To Patient3
- Death2
LIFEPAK CR Plus and LIFEPAK Express defibrillators models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)3 deaths124 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)1 death118 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)29 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99427Automated external defibrillators (non-wearable)26 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)19 reports
- LIFEPAK® CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)18 reports
- LIFEPAK® CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)17 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 97403Automated external defibrillators (non-wearable)8 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)6 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)4 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 97403Automated external defibrillators (non-wearable)4 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)3 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 97403Automated external defibrillators (non-wearable)3 reports
- LIFEPAK® CR Plus and LIFEPAK Express defibrillators 99427Automated external defibrillators (non-wearable)3 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)2 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)2 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99427Automated external defibrillators (non-wearable)2 reports
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403Automated external defibrillators (non-wearable)1 report
- 1 report
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 97403Automated external defibrillators (non-wearable)1 report
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 97403Automated external defibrillators (non-wearable)1 report
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 80427Automated external defibrillators (non-wearable)1 death1 report
- LIFEPAK CR Plus and LIFEPAK Express defibrillators 97403Automated external defibrillators (non-wearable)1 report
- LIFEPAK® CR Plus and LIFEPAK Express defibrillators 80403Automated external defibrillators (non-wearable)1 report
- LIFEPAK® CR Plus and LIFEPAK Express defibrillators 80403Automated external defibrillators (non-wearable)1 report
Recent LIFEPAK CR Plus and LIFEPAK Express defibrillators adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJan 12, 2026Power 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 24048014 ↗MalfunctionJan 2, 2026Power 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 23945255 ↗MalfunctionDec 15, 2025Power 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 USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23811016 ↗MalfunctionDec 14, 2025Power 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 USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799823 ↗MalfunctionNov 13, 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 PATIENT INVOLVED IN THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23541574 ↗MalfunctionOct 22, 2025Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEVICE IS UNABLE TO POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357566 ↗MalfunctionOct 22, 2025Failure to Deliver Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Shock/Stimulation; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED A PATIENT DEATH AFTER USE OF THE DEVICE. THE CUSTOMER WAS UNSURE IF THE DEVICE DELIVERED DEFIBRILLATION AS INTENDED.
Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions
MAUDE report 23357371 ↗MalfunctionJul 24, 2025Power 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 22588976 ↗MalfunctionJun 30, 2025Power 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 22368196 ↗MalfunctionJun 26, 2025Power 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 22337529 ↗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 ↗
Other Physio-Control, Inc. products
- LIFEPAK 15 monitor/defibrillator93 models · 4,675 reports · 12 recalls
- LIFEPAK CR28 models · 2,307 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors23 models · 1,382 reports · 1 recall
- LIFEPAK 1000 defibrillator5 models · 279 reports · 1 recall
- LIFEPAK2 models · 57 reports · 1 recall
- EDGE SYSTEM4 models · 81 reports
- LIFEPAK 12 defibrillator/monitor19 models · 71 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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