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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Boston Scientific Corporation: Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

Agency Publication Date: September 13, 2019
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Affected Products

Product: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

Model A209, Serial Number (Use Before Date) - 213729 (7/24/2019), 213859 (7/26/2019), 213891 (7/27/2019), 213896 (7/27/2019), 213898 (7/27/2019), 213901 (7/27/2019), 213902 (7/27/2019), 213904 (7/27/2019), 213910 (7/27/2019), 213919 (7/27/2019), 213921 (7/27/2019), 213937 (7/27/2019), 213938 (7/27/2019), 213943 (7/27/2019), 213946 (7/27/2019), 213961 (7/28/2019), 213972 (7/28/2019), 213975 (7/28/2019), 213976 (7/28/2019), 213979 (7/28/2019), 213982 (7/28/2019), 213983 (7/28/2019), 214020 (7/31/2019), 214030 (7/31/2019), 214032 (7/31/2019), 214036 (7/31/2019), 214042 (7/31/2019), 214083 (7/31/2019);

Product: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

Model A219, Serial Number (Use Before Date) - 213636 (7/21/2019), 213637 (7/21/2019), 213638 (7/21/2019), 213639 (7/21/2019), 213640 (7/21/2019), 213641 (7/21/2019), 213642 (7/21/2019), 213643 (7/21/2019), 213644 (7/21/2019), 213645 (7/21/2019), 213646 (7/21/2019), 213647 (7/21/2019), 213648 (7/21/2019), 213649 (7/21/2019), 213650 (7/21/2019), 213651 (7/21/2019), 213652 (7/21/2019), 213653 (7/21/2019), 213654 (7/21/2019), 213655 (7/21/2019), 213656 (7/21/2019), 213657 (7/21/2019), 213658 (7/21/2019), 213659 (7/21/2019), 213660 (7/21/2019), 213661 (7/21/2019), 213662 (7/21/2019), 213663 (7/21/2019), 213665 (7/21/2019), 213666 (7/21/2019), 213667 (7/21/2019), 213668 (7/21/2019), 213669 (7/21/2019), 213670 (7/21/2019), 213671 (7/21/2019), 213672 (7/21/2019), 213673 (7/21/2019), 213674 (7/21/2019), 213675 (7/21/2019), 213676 (7/21/2019), 213677 (7/21/2019), 213678 (7/21/2019), 213679 (7/21/2019), 213680 (7/21/2019), 213681 (7/21/2019), 213682 (7/21/2019), 213683 (7/21/2019), 213684 (7/21/2019), 213685 (7/21/2019), 213686 (7/24/2019), 213687 (7/24/2019), 213688 (7/24/2019), 213689 (7/24/2019), 213690 (7/24/2019), 213691 (7/24/2019), 213692 (7/24/2019), 213693 (7/24/2019), 213694 (7/24/2019), 213695 (7/24/2019), 213696 (7/24/2019), 213697 (7/24/2019), 213698 (7/24/2019), 213699 (7/24/2019), 213700 (7/24/2019), 213701 (7/24/2019), 213702 (7/24/2019), 213703 (7/24/2019), 213704 (7/24/2019), 213705 (7/24/2019), 213706 (7/24/2019), 213707 (7/24/2019), 213708 (7/24/2019), 213709 (7/24/2019), 213710 (7/24/2019), 213712 (7/24/2019), 213713 (7/24/2019), 213714 (7/24/2019), 213715 (7/24/2019), 213716 (7/24/2019), 213717 (7/24/2019), 213718 (7/24/2019), 213719 (7/24/2019), 213720 (7/24/2019), 213721 (7/24/2019), 213722 (7/24/2019), 213723 (7/24/2019), 213724 (7/24/2019), 213726 (7/24/2019), 213727 (7/24/2019), 213728 (7/24/2019), 213730 (7/24/2019), 213731 (7/24/2019), 213732 (7/24/2019), 213733 (7/24/2019), 213734 (7/24/2019), 213735 (7/24/2019), 213736 (7/24/2019), 213737 (7/24/2019), 213738 (7/24/2019), 213739 (7/24/2019), 213740 (7/24/2019), 213741 (7/24/2019), 213742 (7/24/2019), 213743 (7/24/2019), 213744 (7/24/2019), 213745 (7/24/2019), 213746 (7/25/2019), 213747 (7/25/2019), 213748 (7/25/2019), 213749 (7/25/2019), 213750 (7/25/2019), 213751 (7/25/2019), 213752 (7/25/2019), 213753 (7/25/2019), 213754 (7/25/2019), 213755 (7/25/2019), 213756 (7/25/2019), 213757 (7/25/2019), 213758 (7/25/2019), 213759 (7/25/2019), 213760 (7/25/2019), 213761 (7/25/2019), 213762 (7/25/2019), 213763 (7/25/2019), 213764 (7/25/2019), 213765 (7/25/2019), 213766 (7/25/2019), 213767 (7/25/2019), 213768 (7/25/2019), 213769 (7/25/2019), 213770 (7/25/2019), 213771 (7/25/2019), 213772 (7/25/2019), 213773 (7/25/2019), 213774 (7/25/2019), 213775 (7/25/2019), 213776 (7/25/2019), 213777 (7/25/2019), 213778 (7/25/2019), 213779 (7/25/2019), 213780 (7/25/2019), 213782 (7/25/2019), 213783 (7/25/2019), 213784 (7/25/2019), 213785 (7/25/2019), 213786 (7/25/2019), 213787 (7/25/2019), 213788 (7/25/2019), 213789 (7/25/2019), 213790 (7/25/2019), 213791 (7/25/2019), 213792 (7/25/2019), 213793 (7/25/2019), 213794 (7/25/2019), 213795 (7/25/2019), 213796 (7/25/2019), 213797 (7/25/2019), 213798 (7/25/2019), 213799 (7/25/2019), 213800 (7/25/2019), 213801 (7/25/2019), 213802 (7/25/2019), 213803 (7/25/2019), 213804 (7/25/2019), 213805 (7/25/2019), 213806 (7/25/2019), 213807 (7/25/2019), 213808 (7/25/2019), 213809 (7/25/2019), 213810 (7/25/2019), 213811 (7/25/2019), 213812 (7/25/2019), 213813 (7/25/2019), 213814 (7/25/2019), 213815 (7/25/2019), 213816 (7/26/2019), 213817 (7/26/2019), 213818 (7/26/2019), 213819 (7/26/2019), 213820 (7/26/2019), 213821 (7/26/2019), 213822 (7/26/2019), 213823 (7/26/2019), 213824 (7/26/2019), 213826 (7/26/2019), 213827 (7/26/2019), 213828 (7/26/2019), 213830 (7/26/2019), 213831 (7/26/2019), 213832 (7/26/2019), 213833 (7/26/2019), 213834 (7/26/2019), 213835 (7/26/2019), 213836 (7/26/2019), 213837 (7/26/2019), 213838 (7/26/2019), 213839 (7/26/2019), 213840 (7/26/2019), 213841 (7/26/2019), 213843 (7/26/2019), 213844 (7/26/2019), 213845 (7/26/2019), 213846 (7/26/2019), 213847 (7/26/2019), 213848 (7/26/2019), 213849 (7/26/2019), 213850 (7/26/2019), 213851 (7/26/2019), 213852 (7/26/2019), 213853 (7/26/2019), 213854 (7/26/2019), 213855 (7/26/2019), 213856 (7/26/2019), 213857 (7/26/2019), 213858 (7/26/2019), 213860 (7/26/2019), 213861 (7/26/2019), 213862 (7/26/2019), 213863 (7/26/2019), 213864 (7/26/2019), 213865 (7/26/2019), 213866 (7/26/2019), 213867 (7/26/2019), 213868 (7/26/2019), 213869 (7/26/2019), 213870 (7/26/2019), 213871 (7/26/2019), 213872 (7/26/2019), 213874 (7/26/2019), 213875 (7/26/2019), 213876 (7/26/2019), 213877 (7/26/2019), 213878 (7/26/2019), 213879 (7/26/2019), 213880 (7/26/2019), 213881 (7/26/2019), 213882 (7/26/2019), 213883 (7/26/2019), 213884 (7/26/2019), 213885 (7/26/2019), 213886 (7/27/2019), 213887 (7/27/2019), 213888 (7/27/2019), 213889 (7/27/2019), 213890 (7/27/2019), 213892 (7/27/2019), 213893 (7/27/2019), 213894 (7/27/2019), 213895 (7/27/2019), 213897 (7/27/2019), 213899 (7/27/2019), 213900 (7/27/2019), 213903 (7/27/2019), 213905 (7/27/2019), 213907 (7/27/2019), 213908 (7/27/2019), 213909 (7/27/2019), 213911 (7/27/2019), 213912 (7/27/2019), 213913 (7/27/2019), 213914 (7/27/2019), 213915 (7/27/2019), 213916 (7/27/2019), 213917 (7/27/2019), 213918 (7/27/2019), 213920 (7/27/2019), 213922 (7/27/2019), 213923 (7/27/2019), 213924 (7/27/2019), 213925 (7/27/2019), 213926 (7/27/2019), 213927 (7/27/2019), 213928 (7/27/2019), 213929 (7/27/2019), 213930 (7/27/2019), 213931 (7/27/2019), 213933 (7/27/2019), 213934 (7/27/2019), 213935 (7/27/2019), 213936 (7/27/2019), 213939 (7/27/2019), 213940 (7/27/2019), 213941 (7/27/2019), 213942 (7/27/2019), 213944 (7/27/2019), 213945 (7/27/2019), 213947 (7/27/2019), 213948 (7/27/2019), 213949 (7/27/2019), 213950 (7/27/2019), 213951 (7/27/2019), 213952 (7/27/2019), 213953 (7/27/2019), 213954 (7/27/2019), 213955 (7/27/2019), 213956 (7/28/2019), 213957 (7/28/2019), 213958 (7/28/2019), 213959 (7/28/2019), 213960 (7/28/2019), 213962 (7/28/2019), 213963 (7/28/2019), 213964 (7/28/2019), 213965 (7/28/2019), 213966 (7/28/2019), 213967 (7/28/2019), 213968 (7/28/2019), 213969 (7/28/2019), 213970 (7/28/2019), 213971 (7/28/2019), 213973 (7/28/2019), 213974 (7/28/2019), 213977 (7/28/2019), 213978 (7/28/2019), 213980 (7/28/2019), 213981 (7/28/2019), 213984 (7/28/2019), 213985 (7/28/2019), 213986 (7/28/2019), 213988 (7/28/2019), 213989 (7/28/2019), 213990 (7/28/2019), 213991 (7/28/2019), 213992 (7/28/2019), 213993 (7/28/2019), 213995 (7/28/2019), 213996 (7/28/2019), 213997 (7/28/2019), 213998 (7/28/2019), 213999 (7/28/2019), 214000 (7/28/2019), 214001 (7/28/2019), 214002 (7/28/2019), 214003 (7/28/2019), 214004 (7/28/2019), 214005 (7/28/2019), 214006 (7/31/2019), 214007 (7/31/2019), 214008 (7/31/2019), 214009 (7/31/2019), 214010 (7/31/2019), 214011 (7/31/2019), 214012 (7/31/2019), 214013 (7/31/2019), 214014 (7/31/2019), 214016 (7/31/2019), 214017 (7/31/2019), 214018 (7/31/2019), 214019 (7/31/2019), 214021 (7/31/2019), 214022 (7/31/2019), 214023 (7/31/2019), 214024 (7/31/2019), 214025 (7/31/2019), 214026 (7/31/2019), 214027 (7/31/2019), 214028 (7/31/2019), 214031 (7/31/2019), 214033 (7/31/2019), 214034 (7/31/2019), 214035 (7/31/2019), 214037 (7/31/2019), 214038 (7/31/2019), 214039 (7/31/2019), 214040 (7/31/2019), 214041 (7/31/2019), 214043 (7/31/2019), 214044 (7/31/2019), 214045 (7/31/2019), 214046 (7/31/2019), 214047 (7/31/2019), 214048 (7/31/2019), 214050 (7/31/2019), 214051 (7/31/2019), 214052 (7/31/2019), 214053 (7/31/2019), 214054 (7/31/2019), 214055 (7/31/2019), 214056 (7/31/2019), 214057 (7/31/2019), 214058 (7/31/2019), 214059 (7/31/2019), 214060 (7/31/2019), 214061 (7/31/2019), 214063 (7/31/2019), 214064 (7/31/2019), 214065 (7/31/2019), 214066 (7/31/2019), 214067 (7/31/2019), 214068 (7/31/2019), 214069 (7/31/2019), 214070 (7/31/2019), 214071 (7/31/2019), 214072 (7/31/2019), 214073 (7/31/2019), 214074 (7/31/2019), 214076 (7/31/2019), 214077 (7/31/2019), 214079 (7/31/2019), 214080 (7/31/2019), 214081 (7/31/2019), 214082 (7/31/2019), 214084 (7/31/2019), 214085 (7/31/2019)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83558
Status: Active
Manufacturer: Boston Scientific Corporation
Manufactured In: United States
Units Affected: 2 products (28 devices; 404 devices)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.