Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;

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: 1000100; UDI-DI: 00813502012828; Serial Numbers: 417756 417055 417820 417817 417818 416967 416968 417054 417056 417057 417058 417819 417821 417042 416991 417043 417024 417025 417026 417027 417028 417234 417235 417236 416989 416990 416992 416993 417040 417041 416864 416865 416866 416867 416962 416959 416887 416888 416963 417237 417238 416897 416869 416872 416873 416886 416961 416960 417833 416870 416871 416855 416854 416858 417244 417246 417245 416884 416885 417061 417062 417063 417815 417269 417270 417271 417272 417785 417786 417768 417769 417770 417771 417239 417240 417242 417243 417060 417247 417808 417809 417811 417814 417273 417782 417783 417784 417937 417938 417939 417940 417941 417498 417264 417265 417266 417267 417268 417955 417956 417494 417495 417465 417466 417467 418015 418018 418019 417816 417952 417953 417954 417497 417464 418016 418017 418732 418733 418715 418716 418717 418718 417496 418700 418701 418702 416859 416860 416861 416862 416863 418729 418730 417249 417250 417251 417252 419011 418699 418703 418175 418176 418177 418731 420411 418744 418745 418746 418253 420973 420985 420986 420987 420988 420989 418170 418172 418020 418021 420410 418747 418748 418249 418250 418251 418252 418022 418024 420974 419093 419094 419095 419096 419097 418256 418257 420441 420442 420412 420413 418053 418054 420445 420446 420447 420448 418254 418255 417604 417605 417606 417607 417608 417659 418154 418157 417660 417661 417662 417663 420414 418050 418051 418052 420535 420525 420527 420526 418258 418811 418856 418857 418858 420990 420992 418972 420991 420994 418973 418974 418975 418976 420530 420531 420532 420533 420425 417482 417483 417973 417974 420534 420426 420427 420428 420429 418049 417590 417591 417592 417593 417480 417481 417509 417510 417512 417513 418143 418135 418136 418138 418045 418046 418047 418048 417468 417589 416857 416856 419012 419013 419014 419015 418141 417832 417836 420538 420539 420662 420663 420540 420542 420626 420627 420628 421156 421159 420537 420664 420543 420544 418860 418861 418863 418864 421170 421171 421172 420610 420611 420612 420613 420614 420625 420589 420901 420902 420904 418986 420585 420586 420588 420820 420821 420822 420823 416889 416891 420816 420817 420818 420819 420836 420837 420838 420839 416892 416893 418987 418988 418989 421173 421174 420835 420935 420937 420938 420939 421190 421191 421192 421194 421617 421618 421619 421620 421621 421567 421568 421569 421570 421571 421532 421533 421534 421535 421536 420943 421592 421593 421594 421595 421596 421208 421209 420941 420942 420944 421582 421583 421362 421363 421233 421232 421231 421230 421229 421368 421367 421366 421365 421358 421357 421356 421355 421427 421587 422134 421805 421861 421364 421428 422367 422359 421588 422364 422133 422132 421802 422124 422126 422129 422130 421806 421859 422122 422368 422369 422127 422128 422131 422363 422135 421803 422362 422361 422360 422358 421857 421860 422377 422376 422375 422374 422373 424152 424153 424154 424155 424156 424162 424161 424160 424159 424158 420464 420463 420462 420461 420460 424710 424709 424708 424151 424150 424149 424148 424147 422370 422371 422139 422138 422137 424707 424706 424219 424220 424221 424222 424183 424184 424185 424187 424730 422141 417248 424173 424174 424175 424176 424177 424218 424729 424728 424727 424712 424713 424714 424180 418812 418813 420629 421155 424711 424181 428091 427996 427997 427998 428117 428118 427970 427971 427972 427973 427941 427942 427943 428089 428090 428092 428093 427995 427314 424715 427061 424723 424724 424721 424716 424717 427940 427974 427975 427976 427977 427978 428064 428065 428067 428068 427994 427265 427266 427267 427268 427269 427270 427317 427318 427369 427058 427060 427375 427376 427377 427378 427347 427348 427344 427345 427315 427316 427370 427371 427372 427373 427354 427358 427644 427057 427356 427357 424718 424720 427062 427063 427064 427070 427071 427075 427263 427264 427355 427065 427066 427077 427078 427079 427080 427068 427069 427

Risk classification

Class II

Area (FDA)

device

Country

United States