LIFEPAK CR2Recalls & reported problems across all models
Physio-Control, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,307
- Deaths reported
- 8
- Injuries reported
- 2
- Recalls
- 0
We found 8 models of LIFEPAK CR2 by Physio-Control, Inc. in the FDA's device registry (GUDID). Together they are named in 2,307 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2019 and Apr 2, 2026 — classified as 8 deaths, 2 injuries, 2,297 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1,731 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 CR2 problems
Device problems
- Detachment of Device or Device Component1,731
- Failure to Power Up319
- Electrical /Electronic Property Problem65
- No Audible Prompt/Feedback42
- Failure to Sense41
- Audible Prompt/Feedback Problem39
- Component Missing34
- Failure to Deliver Shock/Stimulation32
Patient problems
- No Clinical Signs, Symptoms or Conditions2,280
- No Patient Involvement45
- Cardiac Arrest10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Death1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Ventricular Fibrillation1
LIFEPAK CR2 models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LIFEPAK CR2 99512Automated external defibrillators (non-wearable)8 deaths1,502 reports
- LIFEPAK CR2 99512Automated external defibrillators (non-wearable)191 reports
- LIFEPAK CR2 99512Automated external defibrillators (non-wearable)167 reports
- LIFEPAK CR2 99512Automated external defibrillators (non-wearable)136 reports
- LIFEPAK CR2 99512Automated external defibrillators (non-wearable)94 reports
- LIFEPAK CR2 99512Automated external defibrillators (non-wearable)83 reports
- LIFEPAK CR2 99512Automated external defibrillators (non-wearable)75 reports
- LIFEPAK CR2 99512Automated external defibrillators (non-wearable)59 reports
Recent LIFEPAK CR2 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Failure to Deliver Energy
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE DOES NOT DELIVER DEFIBRILLATION ENERGY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766322 ↗MalfunctionMar 18, 2026Failure to Deliver Energy
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE DEVICE WOULD NOT DELIVER DEFIBRILLATION ENERGY.THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626897 ↗MalfunctionDec 29, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE WAS UNABLE TO DELIVER A SHOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23916790 ↗MalfunctionDec 17, 2025Failure to Power Up; Failure to Power Up
A CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, IT WAS OBSERVED THAT THE DEVICE WOULD NOT POWER ON WHEN THE LID IS OPENED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831623 ↗MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE¿S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433136 ↗MalfunctionSep 25, 2025Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON WHEN THE DEVICE LID WAS ACTIVATED. 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 23143129 ↗MalfunctionAug 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING THE MAGNET FROM THE LID OF THE DEVICE. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY WHEN THE LID IS ACTIVATED, WHICH CAN CAUSE A DELAY IN DEFIBRILLATION THERAPY 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 22921917 ↗MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE¿S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LED TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22583438 ↗MalfunctionApr 17, 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 MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21855226 ↗MalfunctionFeb 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE¿S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21494550 ↗MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET. IN THIS STATE, THE DEVICE WOULD NOT DETECT THE LID BEING OPENED OR CLOSED, AND THEREFORE WOULD NOT AUTOMATICALLY POWER ON OR OFF WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20743699 ↗MalfunctionNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USERS HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662471 ↗MalfunctionNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THERE WAS AN ISSUE WITH THEIR DEVICE'S LID MAGNET. THE LID MAGNET CONTROLS THE DEVICE AUTOMATICALLY POWERING ON WHEN THE LID IS OPENED. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651903 ↗MalfunctionNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THERE WAS AN ISSUE WITH THEIR DEVICE'S LID MAGNET. THE LID MAGNET CONTROLS THE DEVICE AUTOMATICALLY POWERING ON WHEN THE LID IS OPENED. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651901 ↗MalfunctionOct 17, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
A CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, IT WAS OBSERVED THAT THE DEVICE WOULD NOT PROVIDE DEFIBRILLATION ENERGY. AS A RESULT, 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 20477723 ↗
Other Physio-Control, Inc. products
- LIFEPAK 15 monitor/defibrillator93 models · 4,675 reports · 12 recalls
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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