A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Reason for recall: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance. Distribution: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands. Quantity: 156,329 units (59,937 US, 96,792 OUS) in total Lot/code info: U125 - UDI-DI: 00802526559389, 00802526559396, 00802526577109, 00802526578793, 00802526577024, Serial Numbers: 100319 100323 100329 100331 100333 100379 100380 100384 100385 100386 100390 100392 100439 100448 100452 100453 100462 100466 100467 100480 100481 100482 100485 100486 100495 100496 100497 100498 100499 100500 100502 100505 100506 100510 100514 100515 100517 100518 100524 100526 100539 100540 100541 100546 100548 100549 100552 100585 100650 100653 100656 100657 100658 100690 100692 100693 100697 100699 100700 100701 100703 100707 100711 100716 100721 100722 100723 100725 100726 100730 100731 100733 100735 100740 100743 100746 100748 100751 100754 100755 100756 100757 100758 100759 100760 100761 100763 100764 100767 100768 100770 100772 100774 100775 100776 100777 100778 100779 100780 100781 100784 100786 100788 100789 100790 100792 100793 100799 100801 100802 100803 100805 100813 100814 100818 100823 100830 100833 100843 100846 100854 100864 100866 100870 100871 100873 100877 100884 100886 100891 100910 100912 700042 700066 700191 700272 700277 700306 700507 700582 700630 700713 700726 700735 700762 700796 700801 700802 700805 700820 700832 700834 700837 700839 700852 700853 700854 700856 700860 700863 700867 700985 701002 701003 701008 701015 701023 701033 701060 701104 701156 701168 701232 701485 701520 701560 701562 701563 701564 701566 701569 701570 701571 701573 701574 701579 701580 701586 701587 701593 701599 701600 701601 701603 701604 701606 701609 701612 701
00802526559389, 00802526559396, 00802526577109, 00802526578793, 00802526577024, 00802526559402, 00802526559419, 00802526576522, 00802526578120, 00802526577031, 00802526593284
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.