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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2966-2024

Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;

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: 1000211; UDI-DI: 00813502012453; Serial Numbers: 378534 379682 379683 379686 379692 379693 379694 379695 381645 381249 381250 381251 381252 369147 381644 381643 379689 381642 381259 369414 381258 381260 368474 381255 381254 379589 381257 385162 381256 379684 385163 385164 377016A 379690 385157 385158 385181 385166 385167 379591 381248 385168 385169 385174 385183 385170 385177 385535 379696 385540 368769 385666 381641 385667 385555 385644 385645 379588 385557 379685 385558 385538 385552 385178 385559 385620 385553 385554 385643 385641 386021 385171 385668 385619 381262 385671 381261 385672 385673 385674 385669 385537 385675 385688 378530 385184 385689 386037 386036 379691 386025 386126 386039 385536 386130 386136 386128 373298 386133 386134 385539 385175 386135 385159 386043 386058 386142 386060 386143 386144 386145 386147 385686 386149 385616 385670 386137 385551 386131 385542 386127 387494 387513 385617 387492 385543 387514 386023 387490 386150 385176 385541 386132 387521 387522 387520 387510 387497 387496 387509 386063 385544 386141 387515 387516 387517 385173 386064 387519 387529 387500 387501 387503 387524 386148 386022 386065 387511 387502 387824 387530 385556 404252 385642 387822 387823 387495 387534 387508 404249 404268 404248 386038A 387528 385548 387512 406345 386040 405175 405174 387523 405176 405177 405168 405169 405170 387518 404250 405171 406158 405172 404270 387527 406162 385549 387531 385179 385690 385546 387525 386140 385618 405471 405472 405464 387499 406342 405707 406168 406171 405704 404263 405705 406170 385180 386138 386129 406161 406172 387533 406159 387504 387825 405173 404271 404745 404251 406169 404284 404285 404698 404699 386057 387505 404288 404283 405466 405467 404696 404697 404304 387826 404307 404303 404286 386062 387526 404264 404267 404305 406160 404982 385165 406144A 406188 406189 406192 405858 404979 405859 405862 406173 385545 406191 405860 386059 406175 387507 404981 404266 406176 406343 404289 404290 405463A 405246 406166A 404978 387532 405245 385155 404272 405465 405968A 406190 387498 405703 404287 387506 405706 386045 385687 404292 435952 435955 436113 435951 436119 436121 436154 435948 436117 436112 436152 435953 435937 435816 436115 436116 436118 435815 435813 435812 436153 438800 438867 435950 438866 435947 438868 436120 438864 439360 435881 439477 439357 439361 438722 437231 437230 436155 438719 438801 439359 438718 437228 438717 435814 438721 438714 437682 438799 439481 438716 436114 437909 435939 438803 439479 438986 437908 437903 438865 439021 438988 439022 438985 437232 439521 438723 439523 439519 439522 437683 437904 438987 435954 439023 439520 439358 438460 438462 438463 437907 436156 438720 437943 440698 437686 440700 440719 440720 440742 435940 437685 438989 437901 438459 440717 439020 449501 440940 449502 449503 440941 435956 438461 437944 440697 449587 449586 437941 449499 449588 449982 440668 438802 449979 440721 440745 440671 449952 439736 439918 439685 438715 451011 451010 439480 438735 439638 439639 440939 440701 437905 453561 453562 453563 437902 437684 439922 449949 451012 451013 453729 449980 449951 453542 453565 453760 453564 453543 439640 440669 449981 453545 453757 435949 458822 458821 458824 451014 439642 453544 458969 456795 459088 458972 458967 458965 458970 458971 459907 439921 459908 459087 459089 459085 458823 459086 460233 458974 460234 459906 461025 460987 440718 460986 460988 460231 461028 440744 458973 461024 449950 461463 460230 461027 462320 453759 461464 462920 461462 449585 462922 462924 462929 462923 459909 462921 462926 462927 461068 464455 464456 464457 462925 462928 464460 464463 458966 464464 466629 466631 464462 466630 466173 466632 466633 461467 461469 464469 437940 458968 439919 464458 461066 466799 459905 461468 456796 462319 464466 460232 460985 461471 464459 464461 466796 463950 439941 461065 464468 469292 469966 469288 466798 469964 461067 469283 469967 453758 469284 469287 461466 469499 469502 469286 469290 461064 469291 4729
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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