Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

Recall details

Manufacturer

Abiomed, Inc.

Distributor

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.

Lot

Product Code: 1000482; UDI-DI: 00813502013276; Serial Numbers: 495587 497107 497106 497228 497229 497232 497230 497231 497293 497295 497098 497102 497100 497101 495588 495589 498183 498185 498184 498187 498155 498927 498918 498919 498920 498921 476042A 498922 498916 498915 476040A 498914 498913 499336 498923 498924 498925 498926 499328 499329 499330 499331 499332 499308 499309 499310 499311 499312 469462A 499333 499334 499335 499509 499553 499554 499555 499556 499557 498917 500617 500616 500615 500614 500613 501467 501466 501465 501464 501463 500562 500561 500560 500559 500558 500528 477188A 500531 500527 500530 500529 500598 500597 500596 500595 500594 500603 500602 500605 500604 500606 501757 501758 501759 501760 501761 501762 501763 501764 501765 501766 499278 499279 499280 499281 499282 501754 501755 501756 501689 501692 500928 500929 500930 500931 500932 501208 501209 501211 501212 501688 499777 500311 500310 500309 500308 500307 502692 502693 503906 503907 503908 502694 502695 502696 502697 502698 503905 503923 503926 503927 503928 503849 503850 503851 503852 503853 503924 503925 503544 503547 504309 503545 503546 504310 504311 504312 504987 504313 499508 499511 503904 499776 499773 504258 504608 504606 497099 497103 497105 497104 497297 497294 497296 497326 497323 497325 498186 497327 497324 498156 498154 498157 498153 498244 498245 498243 498246 498380 504605 498379 498378 498381 498382 504819 504822 504823 504726 504727 504728 504634 504635 504636 504637 504638 504365 504364 504624 504625 504626 504627 504628 504724 505135 505136 505137 505138 504830 504831 504832 506454 506455 506435 506436 506437 506438 506439 506440 506442 506443 506456 506457 507045 507046 507047 506489 506490 506491 506492 506493 507048 507072 507073 507060 507061 507063 507050 507051 507052 507053 507069 507070 507071 507074 507075 507076 507077 507594 507595 507596 507597 507598 507641 507639 507640 507642 507643 507944 507949 507950 507951 507952 507953 507095 507096 507097 507098 507964 507965 507966 507967 507968 507989 507990 507991 507992 507993 504820 508235 508873 508874 508875 508876 508877 508234 504725 505134 504607 504833 504829 509268 509269 509270 509271 509333 509283 509284 509285 509286 509287 509334 509335 509336 499337 509337 509431 509432 509433 509434 509435 509241 509242 509260 509258 509259 509298 509299 509302 509296 509293 509692 509695 509297 509295 510762 510761 510760 510758 510441 510445 510363 510361 510362 510365 510426 510428 510429 510430 510444 510442 510516 510517 510518 510519 510520 506458 507059 507062 508236 508238 510733 510734 510799 508237 510800 510801 510802 510727 510726 510725 510724 510723 510556 510559 510558 510795 511928 511927 511926 511925 511924 512228 512227 512226 512225 512224 512238 512237 512236 512235 512234 512568 512567 512565 512566 512564 513052 513181 513259 513260 513262 513057 513058 513056 513054 513055 513183 513180 512278 512277 512276 512923 512921 512922; Batch Numbers: 2025451589 2025451868 2025452571 2025452580 2025452586 2025452590 2025452596 2025452604 2025452613 2025452621 2025452657 2025452661 2025452662 2025452666 2025452694 2025452698 2025452711 2025452715 2025452719 2025452724 2025452728 2025454403 2025454406 2025454409 2025454411 2025454412 2025456500 2025454415 2025454416 2025454419 2025456472 2025454422 2025454423 2025454430 2025454438 2025454440 2025454444 2025454448 2025454452 2025454456 2025454459 2025454462 2025454475 2025454722 2025454725 2025454727 2025454728 2025454730 2025460917 2025454735 2025454737 2025454739 2025456532 2025456542 2025456545 2025456548 2025456551 2025456552 2025456554 2025458834 2025458848 2025458849 2025458855 2025458861 2025458865 2025458880 2025458882 2025458885 2025458888 2025458894 2025458928 2025458930 2025458931 2025458933 2025458935 2025465232 2025459077 2025459002 2025459067 2025459075 2025459092 2025459096 2025459138 2025459142 2025459147 2025459149 2025459153 2025459194 2025459195 2025459205 2025460505 2025460506 2025460507 202

Risk classification

Class II

Area (FDA)

device

Country

United States