LUCAS 99576Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00883873834329), received between Aug 15, 2019 and May 22, 2026 — classified as 9 deaths, 12 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (49 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 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Electrical /Electronic Property Problem

  The customer contacted Stryker to report that their device would stop 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 use associated with the reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262877 ↗
• MalfunctionMay 13, 2026Key or Button Unresponsive/not Working

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE CONTROL PANELS 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. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162659 ↗
• MalfunctionMar 31, 2026Electrical /Electronic Property Problem; Mechanical Jam

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE COMPRESSIONS WHEN ATTEMPTED. 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 24740461 ↗
• MalfunctionMar 30, 2026Electrical /Electronic Property Problem

  THE 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 REPORT OF PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715425 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED UNEXPECTEDLY WHILE IT WAS RUNNING. AS A RESULT, THE DEVICE MAY BE UNABLE TO BE USED FOR AUTOMATIC CPR, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707127 ↗
• MalfunctionMar 25, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED DURING INTERVENTION ON A PATIENT. 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 ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685622 ↗
• MalfunctionMar 24, 2026Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE CONTROLS OF 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. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678219 ↗
• MalfunctionMar 24, 2026Electrical /Electronic Property Problem

  THE 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 24674288 ↗
• MalfunctionMar 24, 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 24672613 ↗
• MalfunctionMar 23, 2026Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, IT WAS OBSERVED 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 WERE NO REPORTS OF HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662836 ↗
• MalfunctionMar 17, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE STOPPED COMPRESSIONS 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. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24623952 ↗
• MalfunctionMar 17, 2026Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE CONTROLS WERE UNRESPONSIVE. 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 24616811 ↗
• MalfunctionMar 17, 2026Electrical /Electronic Property Problem; Key or Button Unresponsive/not Working

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND THEIR DEVICE WOULD NOT RESPOND TO START BUTTON PRESS. AS A RESULT, 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 THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616802 ↗
• MalfunctionMar 10, 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 24558131 ↗
• MalfunctionMar 5, 2026Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE CONTROLS WERE UNRESPONSIVE. 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 24519208 ↗
• MalfunctionMar 4, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED DURING USE. 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. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510820 ↗
• MalfunctionMar 4, 2026Device Alarm System

  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 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 24510576 ↗
• MalfunctionMar 3, 2026Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED DURING PATIENT USE. 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 WERE NO REPORTS OF HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496098 ↗
• MalfunctionMar 3, 2026Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEVICE WOULD NOT PROVIDE COMPRESSIONS WHEN ATTEMPTED. 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 24495338 ↗
• MalfunctionMar 2, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE STOPPED WITH COMPRESSIONS DURING INTERVENTION ON A PATIENT. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482270 ↗
• MalfunctionFeb 27, 2026Electrical /Electronic Property Problem

  THE 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 24468728 ↗
• MalfunctionFeb 25, 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 24442993 ↗
• MalfunctionFeb 24, 2026Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, IT WAS OBSERVED 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 24427021 ↗
• MalfunctionFeb 20, 2026Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT CONTROLS ON THEIR DEVICE ARE UNRESPONSIVE. 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 24399109 ↗
• MalfunctionFeb 19, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY STOPPED DOING COMPRESSIONS DURING A PATIENT EVENT. 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 24386042 ↗