LUCAS™ Chest Compression System 99576 (REF 99576-000024)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00883873904565), received between May 7, 2019 and Sep 28, 2026 — classified as 7 deaths, 9 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (15 reports).

2 FDA recall records name this device's identifier, 2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 13, 2026Open, Classified

   Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).

   Z-2161-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. May 21, 2025Open, Classified

   Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.

   Z-1998-2025 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916254 ↗
• MalfunctionSep 22, 2026Electrical /Electronic Property Problem

  The customer contacted Stryker to report that their device alarmed and stopped. 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 50852444 ↗
• MalfunctionAug 7, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170810 ↗
• MalfunctionMar 18, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS NOT PERFORMING COMPRESSIONS. AS A RESULT, THE DEVICE MAY BE UNABLE TO PERFORM AUTOMATIC CPR ON A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631948 ↗
• MalfunctionMar 5, 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 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 24518317 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S SUPPORT ARM WAS BROKEN AND WOULD NOT STAY LOCKED INTO THE BACK PLATE. AS A RESULT, THE DEVICE MAY BE UNABLE TO PROVIDED AUTOMATIC CPR TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386080 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED. 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 24305433 ↗
• MalfunctionFeb 9, 2026Mechanical Jam

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS ONLY WORKING INTERMITTENTLY. 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 INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299916 ↗
• MalfunctionFeb 5, 2026Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS 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 USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273088 ↗
• MalfunctionFeb 2, 2026Mechanical Jam

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE STOPPED COMPRESSION DURING AN INTERVENTION. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS, IF NEEDED. 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: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242393 ↗
• MalfunctionJan 19, 2026Electrical /Electronic Property Problem; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED DURING AN INTERVENTION WITH A PATIENT. ADDITIONALLY, IT WAS REPORTED THAT THE CONTROL BUTTONS ON THE DEVICE WERE UNRESPONSIVE. 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. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED; HOWEVER, THE CUSTOMER ADVISED STRYKER THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108956 ↗
• MalfunctionJan 6, 2026Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR 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 23974714 ↗
• MalfunctionDec 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE STOPPED COMPRESSIONS. 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 23921300 ↗
• MalfunctionDec 26, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE ALARMS AND NO FUNCTIONS WORK. 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 23896678 ↗
• MalfunctionDec 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE STOPPED WORKING DURING A PATIENT EVENT. AS A RESULT, AUTOMATIC CPR MAY HAVE BEEN UNAVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835367 ↗
• MalfunctionNov 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE STOPPED DURING PATIENT CARE. 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. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED; HOWEVER, THE CUSTOMER ADVISED STRYKER THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614751 ↗
• MalfunctionNov 18, 2025Mechanical Jam; Mechanical Jam

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT DO COMPRESSIONS. 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 INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581587 ↗
• MalfunctionNov 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION, STRYKER OBSERVED THE DEVICE STOPPED PROVIDING AUTOMATED CHEST COMPRESSIONS. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS, IF NEEDED. 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 23528528 ↗
• MalfunctionOct 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE 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 23438842 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE USE OF THEIR DEVICE CAUSED DAMAGE TO THE CHEST OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Tears

  MAUDE report 20687947 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE USE OF THEIR DEVICE CAUSED DAMAGE TO THE CHEST OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Tears

  MAUDE report 20680797 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, LUCAS 2 DEVICE WAS BEING USED ON A PATIENT FOR CHEST COMPRESSIONS AND IT PUT A 2 INCH LACERATION IN THE PATIENT'S CHEST.

  Patient problems: Laceration(s)

  MAUDE report 19387792 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, LUCAS 2 DEVICE WAS BEING USED ON A PATIENT FOR CHEST COMPRESSIONS AND IT PUT A 2 INCH LACERATION IN THE PATIENT'S CHEST.

  Patient problems: Laceration(s)

  MAUDE report 19382407 ↗
• MalfunctionSep 26, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE SUCTION CUP OF THEIR DEVICE TORE WHILE BEING USED ON THE PATIENT. AS A RESULT, THERE IS A POTENTIAL THAT EFFECTIVE CPR WOULD NOT BE PROVIDED, IF NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815875 ↗
• DeathMay 15, 2023Output Problem; Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE STOPPED WORKING DURING PATIENT RESUSCITATION. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931555 ↗