🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: August 21, 2019 Boston Scientific Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boston Scientific Corporation
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2543-2019

Related Recalls

Model Number L211 PROPONENT DR SL MRI Pacemaker

Boston Scientific

Class I - Dangerous

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Aug 20, 2025 Implants & Prosthetics View Details →

Model Number S702, ALTRUA 2 DR SL Pacemaker

Boston Scientific

Class I - Dangerous

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Aug 20, 2025 Implants & Prosthetics View Details →

Model Number U128, VALITUDE CRT-P EL MRI

Boston Scientific

Class I - Dangerous

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Aug 20, 2025 Other Medical Devices View Details →