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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0823-2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

Publicado el 22 de enero de 2025 · Inicio del retiro: 12 de diciembre de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Boston Scientific Corporation
Distribuidor
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
Lote
L201 - UDI-DI: 00802526559044, 00802526578014, 00802526576379, 00802526576874, Serial Number: 760500 100707 100788 100793 100800 100803 100804 100808 100838 100839 713123 714640 714796 715611 715757 715779 715795 715799 715802 715805 715831 715842 715847 715854 715886 715905 715907 715912 715934 715949 715953 715981 715986 715991 715993 716002 716005 716007 716011 716016 716028 716044 716045 716054 716063 716066 716081 716097 716106 716147 716148 716162 716163 716171 716182 716183 716190 716194 716205 716208 716228 716237 716239 716247 716250 716255 716256 716260 716267 716282 716288 716289 716290 716291 716292 716306 716309 716315 716317 716333 716342 716346 716360 716375 716380 716396 716407 716410 716419 716421 716423 716424 716426 716433 716435 716443 716455 716473 716514 716543 716545 716572 716605 716610 716629 716641 716680 716715 716721 716727 716750 716759 716760 716769 716779 716803 716836 716839 716841 716845 716868 716990 716994 716997 717000 717009 717018 717034 717040 717053 717070 717083 717098 717099 717108 717118 717124 717153 717156 717166 717182 717189 717197 717248 717250 717274 717302 717306 717310 717313 717314 717369 717378 717413 717491 717525 717533 717570 717577 717583 717593 717600 717700 717816 717877 717878 717885 717896 717906 717917 717931 717963 717978 717991 717994 717996 718005 718021 718137 718242 718418 718492 718494 718504 718528 718552 718558 718600 718601 718605 718608 718617 718627 718630 718631 718640 718659 718667 718668 718672 718675 718676 718680 718683 718697 718705 718711 718713 718716 718733 718743 718747 718748 718762 718775 718778 718784 718794 718801 718805 718806 718807 718820 718831 718833 718852 718860 718868 718881 718882 718883 718890 718892 718893 718894 718896 718900 718901 718908 718914 718915 718931 718972 718979 718989 718990 719003 719014 719016 719045 719948 723990 724576 724581 724583 724597 724612 724614 724616 724619 724620 724640 724644 724645 724654 724658 724663 724664 724665 724666 724670 724671 724678 724683 724698 724700 724701 724703 724724 724731 724732 724733 724747 724752 724753 724756 724765 724766 724768 724770 724773 724774 724781 724783 724785 724786 724797 724807 724809 724810 724811 724812 724813 724814 724815 724816 724817 724818 724820 724823 724826 724829 724833 724869 724950 724958 724974 724975 724977 724980 724981 725651 725734 725742 725774 725775 725787 725894 725949 726012 726021 726027 726030 726077 726083 726115 726129 726160 726176 726178 726202 726385 726393 726425 726436 726489 726496 726546 726552 726563 726596 726600 726728 726733 726736 726790 726791 726806 726822 732778 732914 732938 732999 733010 733301 733409 733459 734188 735202 735235 735930 736403 736415 736577 737251 737265 737295 737344 737419 737481 737513 737625 737659 737926 737953 737979 737997 737999 738014 738195 738250 738328 738332 738356 738449 738466 738516 738617 738684 738690 738691 738692 738721 738724 738745 738746 738764 738794 738825 738834 738836 738839 739420 739422 739854 739903 739927 739936 739980 740026 740099 740178 740206 740375 741218 741219 741222 741234 741241 741242 741287 741396 741404 741663 741696 741730 741837 741970 742029 742031 742033 742045 742079 742107 742141 742206 742209 742215 742216 742235 742256 742265 742267 742270 742274 742295 742297 742324 742331 742333 742337 742359 742372 742402 742435 742436 742443 742444 742451 742461 742475 742491 742514 742520 742532 742536 742548 742556 742566 742588 742606 742607 742613 742614 742618 742620 742621 742625 742640 742667 742677 742746 742748 742754 742815 742849 742858 742866 742878 742885 742931 742932 742960 742985 743012 743064 743073 743086 743093 743102 743106 743107 743137 743141 743187 743205 743229 743253 743328 743343 743353 743362 743372 743383 743384 743397 743454 743456 743460 743461 743462 743477 743535 743858 743983 743985 743988 743989 744006 744018 744019 744020 744022 744028 744029 744030 744033 744037 744040 744046 744048 744049 744050 744051 744052 744053 744054 744068
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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