LIFEPAK 1000 defibrillatorRecalls & reported problems across all models
Physio-Control, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one LIFEPAK 1000 defibrillator model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 279
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of LIFEPAK 1000 defibrillator by Physio-Control, Inc. in the FDA's device registry (GUDID). Together they are named in 279 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2018 and Aug 12, 2026 — classified as 2 deaths, 277 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (73 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 1000 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, 2025Open, Classified
Due to required inspections not being performed on products/units that have gone through servicing.
Z-2498-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported LIFEPAK 1000 defibrillator problems
Device problems
- Failure to Power Up73
- Electrical /Electronic Property Problem36
- Failure to Sense26
- Failure to Deliver Shock/Stimulation18
- Unexpected Shutdown17
- Device Sensing Problem16
- Failure to Charge16
- Connection Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions178
- No Patient Involvement86
- No Known Impact Or Consequence To Patient15
- Cardiac Arrest5
- Death2
- Asystole1
- No Consequences Or Impact To Patient1
LIFEPAK 1000 defibrillator models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LIFEPAK 1000 defibrillator 99425Automated external defibrillators (non-wearable)1 death188 reports
- LIFEPAK 1000 defibrillator 99425Automated external defibrillators (non-wearable)76 reports
- LIFEPAK® 1000 defibrillator 99425Automated external defibrillators (non-wearable)1 recall0 reports
- LIFEPAK® 1000 defibrillator 99425Automated external defibrillators (non-wearable)1 death14 reports
- LIFEPAK® 1000 defibrillator 97425Automated external defibrillators (non-wearable)1 report
Recent LIFEPAK 1000 defibrillator adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Delayed Charge Time
During annual service Stryker observed that the device's defibrillation charge is delayed. In this state defibrillation therapy may be delayed or not be available if needed. There was no patient involvement reported with the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218756 ↗MalfunctionAug 4, 2026Delayed Charge Time
During preventive maintenance, Stryker observed that the device will not pass the shock time limit test and that defibrillation charge is delayed. 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 50129281 ↗MalfunctionJun 5, 2026Loose or Intermittent Connection
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE LOCKING OF THE BATTERY OF THEIR DEVICE WAS NOT WORKING PROPERLY AND THE BATTERY WAS FREQUENTLY DISCONNECTED FROM THE DEVICE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25408964 ↗MalfunctionFeb 19, 2026Failure to Power Up; Key or Button Unresponsive/not Working
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. FURTHERMORE, DURING EVALUATION IT WAS FOUND THAT THE ON BUTTON WOULD NOT RESPOND. 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 24392219 ↗MalfunctionJan 27, 2026Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE CONTINUOUSLY GIVES THE "CONNECT ELECTRODES" MESSAGE WHEN ATTACHED TO A PATIENT. 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 24190837 ↗MalfunctionJan 15, 2026Connection Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS GIVING A "CONNECT ELECTRODES" MESSAGE, EVEN THOUGH IT IS CONNECTED, DURING TESTING, 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 24080101 ↗MalfunctionJan 7, 2026Failure to Power Up
DURING PREVENTIVE MAINTENANCE, STRYKER OBSERVED THAT THE CUSTOMER'S DEVICE DOES 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 23987642 ↗MalfunctionSep 3, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
A CUSTOMER RETURNED THEIR DEVICE FOR FUNCTIONAL AND PERFORMANCE TESTING. DURING THE DEVICE'S PERFORMANCE INSPECTION PROCEDURE (PIP), STRYKER OBSERVED THE DEVICE DID NOT DELIVER DEFIBRILLATION ENERGY. 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 22952624 ↗MalfunctionJun 25, 2025Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED THE IMPEDANCE TEST. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED, AS THE DEVICE WOULD NOT BE ABLE TO DETECT SHOCKABLE RHYTHM. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328703 ↗MalfunctionMay 16, 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 PATIENT INVOLVEMENT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22037273 ↗MalfunctionApr 22, 2025Power Problem; Power Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S BATTERY PORT IS DAMAGED. IN THIS STATE THE USER CANNOT INSERT THE BATTERY AND 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 21885873 ↗MalfunctionMar 4, 2025Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE HAD AN LOGGED AN EVENT CODE THAT COULD POTENTIALLY INDICATES A DEVICE SENSING PROBLEM. 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 21512741 ↗MalfunctionFeb 26, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE'S KEYPAD WAS UNRESPONSIVE. 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 21468175 ↗MalfunctionFeb 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 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 21416905 ↗MalfunctionDec 27, 2024Fracture; Fracture
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT HOLD THE BATTERY IN THE COMPARTMENT. 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 21026314 ↗
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 CR Plus and LIFEPAK Express defibrillators25 models · 396 reports
- 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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