LIFEPAK CR2 99512 (REF 99512-001266)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00883873824085), received between Dec 14, 2020 and Nov 21, 2024 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (36 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 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 20743699 ↗
• MalfunctionNov 12, 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 WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662471 ↗
• MalfunctionSep 12, 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 20201442 ↗
• MalfunctionSep 3, 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 20123182 ↗
• MalfunctionAug 27, 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 20081238 ↗
• MalfunctionJul 10, 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 19709471 ↗
• MalfunctionJun 4, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT 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 19459641 ↗
• MalfunctionMay 21, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT POWERING UP WHEN OPENING THE LID. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359768 ↗
• MalfunctionMay 20, 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 INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355765 ↗
• MalfunctionMay 20, 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 19354829 ↗
• MalfunctionMar 14, 2024Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT PROVIDE VOICE PROMPTS AS EXPECTED. THIS 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 18903031 ↗
• MalfunctionMar 5, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT DELIVER SHOCK, WHEN ATTEMPTED. THIS ISSUE MAY PREVENT THE DEVICE FROM PROVIDING THERAPY IF IT WERE NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837769 ↗
• MalfunctionFeb 29, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND 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 18805870 ↗
• MalfunctionJan 12, 2024Energy Output Problem; Energy Output Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEFIBRILLATION ENERGY IS OUT OF RANGE. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE A PROPER 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 18508081 ↗
• MalfunctionJan 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 18467287 ↗
• MalfunctionNov 27, 2023Detachment 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 18208370 ↗
• MalfunctionOct 20, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE MADE A LOUD POP. UPON INVESTIGATION IT WAS FOUND THE DEVICE WOULD NOT DELIVER DEFIBRILLATION ENERGY. 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 17973295 ↗
• MalfunctionSep 6, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT TURN ON AS EXPECTED WHEN OPENING THE LID. THIS 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 17694511 ↗
• MalfunctionJul 17, 2023Detachment 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 17339563 ↗
• MalfunctionJun 28, 2023Detachment 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 17215027 ↗
• MalfunctionMay 9, 2023Detachment 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. 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 INVOLVEMENT IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898238 ↗
• MalfunctionMar 24, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT POWER ON AS EXPECTED WHEN THE LID IS OPENED. 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 16614133 ↗
• MalfunctionFeb 22, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE DEVICE WOULD NOT DELIVER THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418828 ↗
• MalfunctionJan 26, 2023Failure to Sense; Failure to Sense

  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 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 ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250693 ↗
• MalfunctionNov 30, 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 EVALUATION IT WAS FOUND THAT THE 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 15887167 ↗

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