FDAFDA · Alimentos y medicamentos·N.º oficial Z-2960-2024
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Publicado el 11 de septiembre de 2024 · Inicio del retiro: 5 de agosto 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 potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Abiomed, Inc.
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.
- Lote
- Product Code: 0048-0047; UDI-DI: 00813502011944; Serial Numbers: 388777 388778 388780 388893 388894 384779 384780 384781 384782 384783 383447 383448 383449 384706 384705 376210 376213 376214 376215 376216 376217 376219 387222 387223 385821 385822 385823 385824 385825 385826 385827 385828 385829 385830 386077 386078 386079 386080 386081 386082 386083 386085 386084 386181 386182 386183 386184 386185 386186 386187 386188 386190 387467 387468 386963 386959 386960 386955 386956 386953 391935 391936 391937 391938 391940 391941 391942 391943 391944 391895 391897 391898 391899 391900 391901 391902 391904 391958 377480 377481 377482 388499 388500 388501 388502 388503 388504 391960 391959 391955 389486 389487 389488 389960 389495 389496 389498 389500 389501 389502 391957 391956 389959 389961 389963 387324 387326 392163 392164 392165 392166 392167 392169 392170 389964 389965 389967 389968 387325 387327 392162 392168 389966 388468 389527 389530 389531 389532 389533 389504 389505 389506 389507 389508 389509 389512 389513 388530 388529 388532 388531 388533 386163 386162 386161 389524 388534 389525 389526 389528 388525A 386165 389539A 386166 386167 386002A 385930A 385997A 385927 390907 390908 386164 385924 385925 385928 385929 390909 390910 390911 392393 392394 392395 392396 392397 392398 392400 392401 392533 389515 389516 389517 389518 392532 392531 392530 389514 389519 389520 389521 389522 389523 392821 392822 392823 392477 392478 392479 392481 392483 392484 392485 392486 392858 392859 392860 392861 392862 392863 392864 392865 392866 392856 392857 392808 392811 392812 392813 392816 392817 392645 392646 392648 392647 392818 392820 392867 392762 392759 391836 392761 392760 392758 391835 391837 391838 391839 391830 391833 391831 391834 392889 392888 393086 393087 393084 393085 392905 392907 392900 392898 392899 392883 392881 392886 392901 392880 392884 392885 392887 392819 392890 392896 392897 392895 392894 392893 392892 392891 393078 427408 427404 427403 427397 427395 427396 427394 427392 427391 427390 427389 428613 428614 428615 428616 428617 428618 428619 428620 428621 427406 427402 427401 427400 427399 428624 428625 428626 428627 428628 428622 429799 431644 431645 431646 431673 431674 431677 431678 431679 431680 431682 429772 429773 429774 429775 429776 429777 429778 429779 430905 430906 429795 429796 429798 431675 431676 432503 432504 432505 432506 432507 431693 432812 432811 432810 432809 432808 432807 432806 432805 432804 432803 433722 433721 433720 433719 433718 433713 433715 433716 433717 433879 432502 432501 432500 432499 432498 433878 433882 433885 433884 433887 433886 435977 435978 435980 435981 435165 435158 435159 435160 435161 435162 435163 435164 435145 435146 435143 435144 435138 435139 435140 435141 435142 435147 433888 433889 433890 433891 433892 433893 433894 433895 433896 433897 438070 438071 438072 438073 435153 435154 392766 392764 392763 438029 438028 438027 438026 438025 438024 438023 438022 438021 438020 435988 435987 435986 435985 438075 438077 438078 438079 435991 435990 435989 435984 435983 435982 438076 438754 438755 438756 438757 438758 438759 438760 438761 438762 438763 438696 438697 438698 438699 438701 438703 438790 438789 438791 438792 438793 438798 438794 438795 438796 438797 435998 435997 435996 435995 435992 452074 452146 452145 452144 452143 452142 452141 452140 452075 452139 453433 453432 452138 453162 453161 453160 453159 455403 455450 455448 455449 455438 455451 455452 455446 455447 455444 455445 455429 455430 455431 455433 455434 455432 455435 455436 455437 455453 455665 455664 455666 455667 455668 455669 455670 455671 455672 455673 455705 455704 455710 455712 455706 455707 455708 455709 455711 487567 487568 487569 487570 487571 487572 487573 487574 487575 477077 477078 477079 477080 477081 474202 474203 474204 474205 474206 474207 474208 474209 474210 474211 474302 474304 474305 474306 474307 474309 474310 474910 474912 474913 474914 474915 474916 474917 477930 477931 477934 477935 477936 478000 478
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.