LIFEPAK 20 and LIFEPAK 20e defibrillator/monitorsRecalls & reported problems across all models
Physio-Control, Inc. · 23 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,382
- Deaths reported
- 17
- Injuries reported
- 2
- Recalls
- 1
We found 23 models of LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors by Physio-Control, Inc. in the FDA's device registry (GUDID). Together they are named in 1,382 adverse event reports in the FDA's MAUDE database, received between Mar 27, 2018 and Aug 25, 2026 — classified as 17 deaths, 2 injuries, 1,363 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (484 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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 20 and LIFEPAK 20e defibrillator/monitors 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.
- Feb 3, 2025Class IIOpen, Classified
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Z-1232-2025 · Root cause: Employee error · Recall details · FDA record ↗
Most reported LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors problems
Device problems
- Electrical /Electronic Property Problem484
- Failure to Power Up329
- Unexpected Shutdown82
- Inappropriate/Inadequate Shock/Stimulation78
- Failure to Deliver Shock/Stimulation72
- Device Sensing Problem63
- Connection Problem48
- Failure to Sense45
Patient problems
- No Clinical Signs, Symptoms or Conditions845
- No Patient Involvement468
- No Known Impact Or Consequence To Patient81
- Cardiac Arrest14
- Death9
- No Consequences Or Impact To Patient7
- Ventricular Fibrillation3
- Asystole2
LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)1 death228 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99402Automated external defibrillators (non-wearable)4 deaths173 reports
- LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)131 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)4 deaths129 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)124 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)5 deaths101 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)91 reports
- LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)79 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)3 deaths78 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99402Automated external defibrillators (non-wearable)77 reports
- LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)73 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)1 recall3 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99402Automated external defibrillators (non-wearable)38 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99402Automated external defibrillators (non-wearable)21 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99402Automated external defibrillators (non-wearable)19 reports
- LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)6 reports
- LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)3 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 97402Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 70402Automated external defibrillators (non-wearable)1 report
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 70402Automated external defibrillators (non-wearable)1 report
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors 99507Automated external defibrillators (non-wearable)1 report
Recent LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Inappropriate/Inadequate Shock/Stimulation
The customer contacted Stryker to report that their device displayed an abnormal energy error during use. 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 50428192 ↗MalfunctionJun 9, 2026Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT 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 25440725 ↗MalfunctionMay 11, 2026Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NO POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145111 ↗MalfunctionApr 30, 2026Failure to Power Up
A CUSTOMER CONTACTED STRYKER TO REPORT THAT 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 USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25041197 ↗MalfunctionApr 28, 2026Failure to Power Up
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017191 ↗MalfunctionApr 15, 2026Electrical /Electronic Property Problem
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD A WHITE SCREEN. AS A RESULT, THE DEVICE MAY HAVE BEEN IN A LOCK UP CONDITION 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 24883689 ↗MalfunctionMar 25, 2026Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE DID NOT POWER ON. 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 24685620 ↗MalfunctionJan 6, 2026Device Sensing Problem
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE PROMPTED A CONNECTION ISSUE WITH THE HANDLES. AS A RESULT, DEFIBRILLATION THERAPY MAY 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 23975099 ↗MalfunctionDec 29, 2025Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT RECOGNIZE THE THERAPY CABLE. 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 23913027 ↗MalfunctionNov 26, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S DISPLAY WAS BLANK/NOT ILLUMINATED. A BLANK DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE 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 23662967 ↗MalfunctionOct 2, 2025Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23199920 ↗MalfunctionSep 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO COMPLETE THE BOOT UP CYCLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23070287 ↗MalfunctionSep 9, 2025Failure to Sense; Failure to Sense
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS NOT RECOGNIZING WHEN THE THERAPY PADS ARE CONNECTED. 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 23003164 ↗MalfunctionSep 5, 2025Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS NOT DETECTING THE THERAPY CABLE WHEN PADS ARE CONNECTED. 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 22985418 ↗MalfunctionAug 21, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN ITS MEMORY THAT IS INDICATIVE OF A DEVICE FAILURE WHICH COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM. THE DEFIBRILLATOR OUTPUT ENERGY COULD BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22869281 ↗
Other Physio-Control, Inc. products
- LIFEPAK 15 monitor/defibrillator93 models · 4,675 reports · 12 recalls
- LIFEPAK CR28 models · 2,307 reports
- 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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