Boston Scientific Corporation: ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

Hazard

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.

Details from the source

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: L301 - UDI-DI: 00802526559174, 00802526559181, Serial Numbers: 100752 100892 100893 100931 100932 100938 100941 100980 100981 100982 100985 100986 100988 100989 100990 100991 100997 101000 101002 101004 101006 101014 101016 101017 101020 101021 101022 101024 101025 101033 101036 101037 101042 101043 101044 101046 101048 101050 101053 101059 101061 101067 101214 101218 101221 101223 101224 101225 101382 101388 101393 101400 101406 101409 101411 101412 101418 101423 101424 101427 101436 101438 101440 101442 101450 101454 101455 101457 101459 101466 101469 101472 101475 101492 101493 101494 101511 101523 101524 101525 101529 101533 101535 101537 101541 101543 101545 101546 101550 101553 101555 101559 101560 101564 101572 101575 101576 101577 101579 101581 101584 101585 101588 101590 101602 101603 101604 101605 101607 101609 101611 101619 101625 101633 101634 101637 101638 101640 101642 101644 101648 101654 101656 101659 101676 101684 101687 101700 101705 101706 101726 101741 101749 101767 101779 101788 101790 101796 101805 101823 101825 101841 101844 101851 101852 101873 101889 101911 101912 101919 101930 101931 101938 101941 101942 101951 101953 101955 101966 101967 101968 101982 101987 101988 101992 101998 102010 102011 102014 102022 102023 102025 102033 102034 102036 102039 102040 102042 102047 102057 102058 102068 102070 102073 102076 102079 102080 102081 102084 102085 102087 102089 102091 102095 102096 102098 102101 102104 102112 102115 102118 102125 102129 102138 102142 10

UPC codes

00802526559174, 00802526559181

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.