LUCAS CPR Chest Compression System 99576Recalls & reported problems
Jolife AB · LUCAS 3, 3.1, IN SHIPPING BOX, JA · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This LUCAS CPR chest compression system performs automated chest compressions. Reports mostly describe the device stopping, alarming, or controls and buttons not responding so it could not give compressions, with two recent reports mentioning internal thoracic artery injury. There are 26 reports naming its identifier, including 2 deaths and 5 injuries. No recalls name this device, and reports rose from 7 in the previous 12 months to 19 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 19
- Deaths reported
- 2
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00883873834282), received between Dec 23, 2024 and Sep 23, 2026 — classified as 2 deaths, 5 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (9 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem9
- Adverse Event Without Identified Device or Use Problem6
- Detachment of Device or Device Component2
- Device Alarm System1
- Key or Button Unresponsive/not Working1
- Mechanical Jam1
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Unspecified Vascular Problem2
- Hemorrhage/Blood Loss/Bleeding1
- Liver Damage/Dysfunction1
- Liver Laceration(s)1
- Skin Tears1
- Unspecified Respiratory Problem1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
The customer contacted Stryker to report that their LUCAS device was unable to secure to the backplate of the device.If a device malfunctions, the device operating instructions indicate that the user is to remove the device and immediately start manual chest compressions.There was no patient use associated with the reported event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863227 ↗InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR LUCAS DEVICE POTENTIALLY CAUSED AN INTERNAL THORACIC ARTERY INJURY TO A PATIENT.
Patient problems: Unspecified Vascular Problem
MAUDE report 25686069 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
The customer contacted Stryker to report that their Lucas device potentially caused an internal thoracic artery injury.
Patient problems: Unspecified Vascular Problem
MAUDE report 25663149 ↗MalfunctionMay 19, 2026Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PROVIDE COMPRESSIONS. IF A DEVICE DOES MALFUNCTION, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO PERFORM MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25214280 ↗MalfunctionMar 19, 2026Key or Button Unresponsive/not Working
THE CUSTOMER CONTACTED STRYKER TO REPORT A BUTTON ON THE CONTROL PANEL WAS NOT FUNCTIONING. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643303 ↗MalfunctionFeb 26, 2026Electrical /Electronic Property Problem
THE DISTRIBUTOR CONTACTED STRYKER TO REPORT THAT A CUSTOMER'S DEVICE WOULD NOT PERFORM COMPRESSIONS. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PROVIDE COMPRESSIONS. IF A DEVICE DOES MALFUNCTION, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO PERFORM MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24462997 ↗MalfunctionFeb 2, 2026Detachment of Device or Device Component
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE BUTTONS ON BOTH ARMS OF THE DEVICE HAVE COME OFF. THIS MAY LEAD TO DEVICE NOT BEING ABLE TO LOCK TO THE BACK PLATE. IN THIS STATE, A DELAY IN CARDIOPULMONARY RESUSCITATION MAY OCCUR. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24242395 ↗MalfunctionFeb 2, 2026Electrical /Electronic Property Problem; Mechanical Jam
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT AN ERROR OCCURRED DURING DEVICE'S POWER-UP, WHICH MADE THE DEVICE UNUSABLE. IN THIS STATE, A DELAY IN CARDIOPULMONARY RESUSCITATION MAY OCCUR. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24242387 ↗MalfunctionJan 16, 2026Electrical /Electronic Property Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED DURING USE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER CHEST COMPRESSIONS IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094596 ↗MalfunctionJan 7, 2026Electrical /Electronic Property Problem
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEVICE ALARMED AND PAUSED. IN THIS STATE, A DELAY IN CARDIOPULMONARY RESUSCITATION MAY OCCUR. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987668 ↗MalfunctionDec 26, 2025Device Alarm System; Electrical /Electronic Property Problem; Device Alarm System; Electrical /Electronic Property Problem
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23897385 ↗MalfunctionDec 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT PERFORMING COMPRESSIONS. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PROVIDE COMPRESSIONS. IF A DEVICE DOES MALFUNCTION, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO PERFORM MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23811824 ↗MalfunctionOct 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A CUSTOMER CONTACTED STRYKER TO REPORT THAT DURING TRAINING THEIR DEVICE ALARMED AND PAUSED. IN THIS STATE, IT WOULD NOT BE ABLE TO PROVIDE COMPRESSIONS, IF NEEDED. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO PERFORM MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23442229 ↗MalfunctionOct 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE PISTON OF THEIR DEVICE WAS STUCK. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PROVIDE COMPRESSIONS. IF A DEVICE DOES MALFUNCTION, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO PERFORM MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437758 ↗DeathJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS USED ON A PATIENT IN CARDIAC ARREST. DURING USE OF THE LUCAS DEVICE, BLEEDING WAS OBSERVED FROM THE TRACHEAL INTUBATION TUBE AND THE NURSE REPORTED A SUSPECTED LUNG INJURY. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Respiratory Problem
MAUDE report 22372739 ↗DeathMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT A PATIENT DEATH. USE OF THE DEVICE MAY HAVE CONTRIBUTED BUT IT IS UNKNOWN HOW THE INJURY CONTRIBUTED.
Patient problems: Liver Laceration(s)
MAUDE report 21994998 ↗InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT A WOUND WAS OBSERVED ON THE PATIENT'S CHEST WHILE USING THE DEVICE. THE PATIENT INVOLVED IN THE REPORTED EVENT DID NOT SURVIVE, HOWEVER IT WAS DETERMINED THAT THE DEVICE DID NOT CAUSE THE DEATH OF THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS VICTIM OF A HOMICIDE.
Patient problems: Skin Tears
MAUDE report 21663376 ↗InjuryJan 22, 2025Sharp Edges; Sharp Edges
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT DURING THE USE OF THEIR LUCAS DEVICE, THE DEVICE'S SUCTION CUP BECAME DAMAGED, CAUSING A 1-2 CM WOUND TO THE PATIENT'S CHEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208204 ↗InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POTENTIALLY CAUSED LIVER DAMAGE DURING PATIENT USE.
Patient problems: Liver Damage/Dysfunction
MAUDE report 21000367 ↗
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- LUCAS 99576Jolife AB · Compressor, cardiac, external2 recalls9 deaths99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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