LIFEPAK CR2 99512 (REF 99512-001264)Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00883873824108), received between Nov 1, 2019 and Oct 7, 2024 — classified as 94 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (58 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 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 20382389 ↗
• MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. 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 USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20376353 ↗
• MalfunctionOct 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. 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 USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357735 ↗
• MalfunctionSep 17, 2024Detachment 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 20234714 ↗
• MalfunctionSep 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. 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 USERS HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20210780 ↗
• MalfunctionSep 9, 2024Failure to Power Up; Detachment of Device or Device Component; Failure to Power Up; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO POWER ON. UPON FURTHER INSPECTION, IT WAS OBSERVED THAT THEIR DEVICE WAS MISSING THE MAGNET FROM THE LID. 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 20168945 ↗
• MalfunctionSep 4, 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 REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137268 ↗
• MalfunctionSep 4, 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 REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137236 ↗
• MalfunctionSep 4, 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 REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137230 ↗
• MalfunctionAug 13, 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 USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973820 ↗
• MalfunctionJul 24, 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 19814638 ↗
• MalfunctionJul 17, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY STRYKER, THE DEVICE FAILED THE LANGUAGE BUTTON TEST. WITHOUT APPROPRIATE LANGUAGE, A USER WOULD NOT UNDERSTAND THE AUDIBLE INSTRUCTIONS ON HOW TO USE THE DEVICE PROPERLY. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759300 ↗
• MalfunctionMay 8, 2024Detachment 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 19270646 ↗
• MalfunctionApr 16, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON WHEN LID OPENED. 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 19113811 ↗
• MalfunctionApr 9, 2024Failure to Power Up; Failure to Power Up

  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 OVERSERVED THAT THE DEVICE INTERMITTENTLY WON'T POWER ON WHEN THE LID WAS OPENED. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070788 ↗
• MalfunctionApr 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, STRYKER OBSERVED THAT THE DEVICE WAS IN A LOCKED-UP STATE. AS A RESULT, DEFIBRILLATION 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 19057705 ↗
• MalfunctionMar 15, 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 18910302 ↗
• MalfunctionMar 11, 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 18873077 ↗
• MalfunctionMar 6, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL HAZARD WITH THEIR DEVICE. DURING EVALUATION, STRYKER OBSERVED THAT THE CUSTOMER'S DEVICE INTERMITTENTLY DOES NOT POWER ON WHEN THE LID IS OPENED. 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 PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853007 ↗
• MalfunctionMar 6, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE DEVICE DOES NOT EMIT AUDIO PROMPTS. 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 18844005 ↗
• MalfunctionJan 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT  THEIR DEVICE DOES NOT SENSE WHEN LID IS 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 USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430010 ↗
• MalfunctionDec 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE MAGNET WAS MISSING FROM THE LID OF THEIR DEVICE. 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 USERS HAS TO PUSH THE POWER BUTTON UNDERNEATH THE LID TO TURN THE DEVICE ON. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407482 ↗
• MalfunctionDec 12, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD DELIVER UNINTENDED DEFIBRILLATION ENERGY. IN THIS STATE, AN INCORRECT DEFIBRILLATION THERAPY WOULD BE DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309662 ↗
• MalfunctionNov 29, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE DISTRIBUTOR 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 DELIVERED ENERGY AT AN UNEXPECTED LEVEL. AS A RESULT INAPPROPRIATE ENERGY MAY BE DELIVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228702 ↗
• MalfunctionNov 20, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR 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 18172365 ↗

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 a