LIFEPAK 15 monitor/defibrillatorRecalls & reported problems across all models
Physio-Control, Inc. · 93 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
12 open recalls name at least one LIFEPAK 15 monitor/defibrillator model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4,675
- Deaths reported
- 55
- Injuries reported
- 11
- Recalls
- 12
We found 93 models of LIFEPAK 15 monitor/defibrillator by Physio-Control, Inc. in the FDA's device registry (GUDID). Together they are named in 4,675 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2018 and Sep 30, 2026 — classified as 55 deaths, 11 injuries, 4,609 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (1,568 reports).
12 FDA recall records name at least one of these models by its device identifier, 12 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. 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
LIFEPAK 15 monitor/defibrillator recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 22, 2025Class IIOpen, Classified
Due to required inspections not being performed on products/units that have gone through servicing.
Z-2497-2025 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
- 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 · names 14 of these models · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0305-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0304-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0303-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0302-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0301-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0300-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0298-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0297-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Z-0296-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported LIFEPAK 15 monitor/defibrillator problems
Device problems
- Unexpected Shutdown1,568
- Electrical /Electronic Property Problem707
- Failure to Power Up670
- Defibrillation/Stimulation Problem388
- Failure to Deliver Shock/Stimulation247
- Key or Button Unresponsive/not Working189
- Failure to Deliver Energy182
- Device Sensing Problem158
Patient problems
- No Clinical Signs, Symptoms or Conditions2,993
- No Patient Involvement983
- No Known Impact Or Consequence To Patient677
- No Consequences Or Impact To Patient43
- Cardiac Arrest40
- Death32
- Ventricular Fibrillation14
- Arrhythmia9
LIFEPAK 15 monitor/defibrillator models
93 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)3 recalls7 deaths755 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 recalls5 deaths540 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 recalls7 deaths402 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 recalls3 deaths376 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 recalls4 deaths273 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)3 recalls189 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)4 deaths234 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 recalls1 death110 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 recalls1 death100 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 recall3 deaths109 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 recalls2 deaths50 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 death141 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 deaths130 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 deaths108 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)3 deaths91 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 recall1 death38 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 death88 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 deaths84 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)77 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 recall1 death26 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 recall16 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 recall7 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)55 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 recall4 reports
- LIFEPAK 15 monitor/defibrillator 97577Automated external defibrillators (non-wearable)1 recall2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 recall0 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)50 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 death44 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)43 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)43 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)36 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)28 reports
- LIFEPAK 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)27 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 death24 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)21 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)19 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)19 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)17 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)16 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)16 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 deaths14 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)14 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)13 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)13 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)13 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)13 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)12 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)11 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)11 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)11 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)10 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)9 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)9 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)9 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)9 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)8 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)7 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)7 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)6 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)5 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 death5 reports
- LIFEPAK 15 monitor/defibrillator 97577Automated external defibrillators (non-wearable)4 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)4 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)3 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)3 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)3 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)3 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)3 reports
- LIFEPAK 15 MONITOR/DEFIBRILLATOR 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)2 reports
- LIFEPAK 15 monitor/defibrillator 97577Automated external defibrillators (non-wearable)1 report
- LIFEPAK 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 15 monitor/defibrillator 99577Automated external defibrillators (non-wearable)1 report
Recent LIFEPAK 15 monitor/defibrillator adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952785 ↗MalfunctionSep 25, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903399 ↗MalfunctionSep 14, 2026Failure to Charge
The customer contacted Stryker to report that their device would not charge during a patient case. In this state the device may not be able to deliver defibrillation therapy if needed. This issue is patient related; however there was no adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756462 ↗MalfunctionSep 2, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564924 ↗MalfunctionAug 31, 2026Intermittent Loss of Power
The customer contacted Stryker to report their device was stuck in a boot loop. 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 50517352 ↗MalfunctionAug 27, 2026Electrical /Electronic Property Problem
The customer contacted Stryker to report that their device would not complete a boot cycle. The customer advised that the device powers on then off. 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 50477362 ↗MalfunctionAug 21, 2026Defibrillation/Stimulation Problem; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50383294 ↗MalfunctionAug 18, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299071 ↗MalfunctionAug 18, 2026Unexpected Shutdown
The customer contacted Stryker to report that their device intermittently turns off. In this state the device may not be able to deliver defibrillation therapy if neededThere was no patient involvement reported with the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50298567 ↗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 ↗MalfunctionAug 7, 2026Failure to Deliver Shock/Stimulation
The customer contacted Stryker to report that their device did not shock. In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient 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 50184195 ↗MalfunctionJul 30, 2026Failure to Charge
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 was unable to charge. In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed. There was no patient involvement reported with the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50080387 ↗MalfunctionJul 29, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50066241 ↗MalfunctionJul 20, 2026Unexpected 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 EXPERIENCED UNEXPECTED SHUTDOWN. 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 25879543 ↗MalfunctionJul 19, 2026Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25867977 ↗
Other Physio-Control, Inc. products
- LIFEPAK CR28 models · 2,307 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors23 models · 1,382 reports · 1 recall
- LIFEPAK CR Plus and LIFEPAK Express defibrillators25 models · 396 reports
- 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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