FDAFDA · Alimentos y medicamentos·N.º oficial Z-2964-2024
Pump 381 Pump Set (US); Product Code: 1000080;
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: 1000080; UDI-DI: 00813502012279; Serial Numbers: 411717 411718 411715 411716 411720 411721 411722 411723 411724 411705 411706 411707 411711 411712 411719 411814 411813 411812 411811 411810 411809 411708 411709 411710 411713 411714 411808 411807 411806 411805 411866 411867 412111 412112 412142 412143 412110 412113 412114 412115 412116 412117 412141 412000 412148 412146 412144 412145 412140 412147 412001 412003 411860 411861 411862 411863 411864 412004 412005 411321 411477 411473 411474 411310 411890 411889 411888 411887 411475 411476 411468 411467 411469 411470 411301 411478 411461 411462 411463 411464 411465 411472 411303 411304 411309 411466 411302 411305 411306 411307 411892 411893 411894 411895 411896 412461 412463 412465 412301 412330 412331 412332 412333 412334 412335 412336 412337 412338 411891 412467 412149 412299 412300 412303 412304 412305 412308 412329 412459 412458 412460 412462 412464 412306 412307 411546 411547 411549 411550 411733 411855 412888 412889 412890 412891 411541 411542 412309 411730 411731 411732 411734 411851 411853 412892 412893 411543 411544 411856 411857 411858 412887 411859 412884 412885 413323 413324 413325 413326 412918 412917 412916 412914 413321 413322 412317 412318 413327 413328 412312 412316 412638 412639 412640 412642 413329 413330 412313 412314 412633 412634 412635 412636 412310 412311 413965 413966 413967 413968 413969 413970 412270 412027 412028 414267 414269 414270 414271 414272 414273 413526 413527 413528 413529 413971 413972 413973 413974 412269 412025 412032 414264 414266 414268 414265 413044 413045 413046 413520 413521 413522 413524 413525 412919 412920 412921 412922 412923 413179 413180 413181 413182 413183 413184 413185 413186 413187 413188 413047 413048 413049 413050 413051 413052 413053 413272 413274 413275 413276 413277 413278 413171 413172 413173 413174 413175 413176 413178 413159 413160 413162 413163 413164 413165 413166 413167 413168 413005 413007 413009 413010 413013 413011 413012 413562 413563 413564 413004 412271 412272 412273 412274 412276 412277 412278 413555 413556 413557 413279 413558 413559 412229 412232 412233 412235 412236 412238 413413 413414 413416 413417 413418 413421 413422 413560 414230 414231 414236 414237 414238 414276 414278 414279 414280 414281 414282 414283 414285 414284 413805 413806 413807 413808 413809 413578 413580 414229 414232 414233 414235 414491 414492 414495 413804 414432 414430 414429 414428 414426 414427 413575 413576 413577 413579 413581 413582 413584 413860 413861 413862 413864 413865 413866 413867 413868 413869 413650 413651 413654 413655 413657 413658 413659 413802 413803 413800 413801 413170 414486 414487 414488 414489 414490 414493 414494 414723 414722 414721 414720 414719 414718 414406 414408 414409 414411 414413 414414 414471 414472 414473 414474 414475 414433 414434 414435 414725 414726 414727 414603 414604 414607 414608 414609 414610 414724 414605 414606 414611 414612 414893 414894 414895 414896 414897 414898 414899 414900 414901 414902 414908 414907 414906 414905 414904 414903 415202 415207 411841 411843 411845 411846 411847 411849 412065 412063 412062 412061 411773 411774 415203 415204 415205 415208 415209 415210 415211 411840 411772 411770 411777 411778 414909 414910 414911 414912 413311 413313 413315 413317 413318 413319 413024 413025 413026 413027 411979 411980 411981 411982 411984 412120 412121 412122 412125 412127 412128 412067 412068 412069 412804 413870 413871 413872 413873 413874 413028 413029 412806 412808 412810 412811 412813 413875 413876 413878 413030 413031 413033 413957 413958 413959 413961 413962 413963 413606 413607 413608 413609 413610 413611 413612 413613 413614 414241 414242 414243 414244 414245 414246 414416 414417 414418 414419 414420 414421 414422 414424 414425 414728 414730 414735 414741 414742 414743 414744 414745 414746 414747 414933 414934 414247 414248 414935 414936 414937 414938 414939 414940 414941 414942 415132 415133 415134 415135 415136 415137 415138 415139 414873 414874 414875 414876 414
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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