LIFEPAK 99512 (REF 99512-001435)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00883873785904), received between Jan 28, 2021 and Sep 5, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 reports).

2 other recalls cover devices cleared under the same FDA submission (P170018); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET. IN THIS STATE, THE DEVICE WOULD NOT DETECT THE LID BEING OPENED OR CLOSED, AND THEREFORE WOULD NOT AUTOMATICALLY POWER ON OR OFF WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145304 ↗
• MalfunctionSep 4, 2024Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, 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 20141965 ↗
• MalfunctionJul 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET. THIS WILL RESULT IN AN INABILITY OF THE DEVICE TO DETECT THE LID BEING OPENED OR CLOSED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824771 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING THE MAGNET FROM THE LID OF THE DEVICE. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY WHEN THE LID IS ACTIVATED, WHICH CAN CAUSE A DELAY IN DEFIBRILLATION THERAPY IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813344 ↗
• MalfunctionApr 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET. IN THIS STATE, THE DEVICE WOULD NOT DETECT THE LID BEING OPENED OR CLOSED, AND THEREFORE WOULD NOT AUTOMATICALLY POWER ON OR OFF WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058216 ↗
• MalfunctionMar 15, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS RECEIVED WITH A BROKEN SEAL ON THE ELECTRODES. 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 18910300 ↗
• MalfunctionFeb 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE¿S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18729795 ↗
• MalfunctionNov 14, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON WHEN THE DEVICE LID WAS ACTIVATED. IN THIS STATE DEFIBRILLATION THERAPY MAY BE DELAYED IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129949 ↗
• MalfunctionOct 18, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, STRYKER OBSERVED THAT THEIR DEVICE WOULD NOT DETECT THE LID BEING OPENED. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957399 ↗
• MalfunctionAug 1, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION, IT WAS FOUND THAT THE DEVICE FAILED TO POWER ON WHEN THE LID WAS OPENED. IN THIS STATE, A DELAY IN DEFIBRILLATION MAY OCCUR, AS THE USER HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435960 ↗
• MalfunctionMay 11, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT POWER ON WHEN THE LID IS OPENED. 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 16915125 ↗
• MalfunctionMay 3, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION STRYKER OBSERVED THAT THE DEVICE WOULD NOT COMPLETE ITS BOOT UP CYCLE. AS A RESULT, 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 16859194 ↗
• MalfunctionDec 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING THE EVALUATION, IT WAS FOUND THAT THE DEVICE¿S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916503 ↗
• MalfunctionNov 8, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO 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 DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757248 ↗
• MalfunctionSep 13, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO 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 15412550 ↗
• MalfunctionAug 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS MISSING THE MAGNETIC PIN IN THE LID. IN THIS STATE, THE DEVICE WILL NOT TURN ON AUTOMATICALLY, WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316512 ↗
• MalfunctionAug 19, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS "DEAD ON ARRIVAL." AS A RESULT, THE DEVICE MAY NOT HAVE BEEN ABLE TO POWER ON TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261595 ↗
• MalfunctionJul 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT TURN ON WHEN THE LID WAS OPENED AND WAS MISSING THE MAGNETIC PIN IN THE LID. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY, WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021597 ↗
• MalfunctionJul 14, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE WAS NOT DELIVERING ENERGY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015385 ↗
• MalfunctionMay 4, 2022Detachment of Device or Device Component; Unexpected Shutdown; Detachment of Device or Device Component; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN DURING PATIENT USE. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE'S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282569 ↗
• MalfunctionOct 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE'S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689963 ↗
• MalfunctionOct 11, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS NOT POWERING ON WHEN THE LID IS OPENED. 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 12606718 ↗
• MalfunctionSep 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS MISSING THE MAGNET FROM THE LID OF THE DEVICE AND AS A RESULT THEIR DEVICE WOULD NOT ACTIVATE WHEN THE LID WAS OPENED. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY WHEN THE LID IS ACTIVATED, WHICH CAN CAUSE A DELAY IN DEFIBRILLATION THERAPY IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546161 ↗
• MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS MISSING THE MAGNET FROM THE LID OF THE DEVICE. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY WHEN THE LID IS ACTIVATED, WHICH CAN CAUSE A DELAY IN DEFIBRILLATION THERAPY IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11247521 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P170018. One submission often covers many models, so check the product and lot details in each record.

• Z-2499-2025 · Jul 22, 2025 · Open, Classified
  LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age
• Z-1189-2021 · Jan 14, 2021 · Open, Classified
  PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads