FDAFDA · Food and drugs·Recall number Z-2961-2024
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Published September 11, 2024 · Recall initiated: August 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
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: 0550-0002; UDI-DI: 00813502011630; Serial Numbers: 384019 384018 384017 384016 383757 383754 383756 383755 384616 384617 384613 384609 384594 384614 384615 384610 384611 384612 384709 384623 384622 384620 384619 384793 384792 384713 384712 384711 384790 384789 384888 384887 384886 384885 384791 384884 384813 384812 384810 384809 384838 384837 384836 384835 384871 384872 384834 384870 384869 397290 397289 393811 393812 393810 393809 397288 393808 397287 397286 395384 395383 394929 395382 395381 394926 394925 394928 394927 395380 398211 398210 398208 398566 398567 398207 400356 400355 400359 400358 400357 398569 400394 400392 400391 400390 403768 403662 403661 403659 403658 403483 403481 403482 403480 403771 403770 403264 397285 397282 397281 397284 397200 397199 397198 397197 397196 397130 397294 397295 397292 397293 397291 397499 397498 397496 397309 397310 397308 397307 397306 397500 397296 398570 397305 397304 397301 397303 397302 403265 403266 403769 404032 404031 404030 404028 403886 403885 403884 403880 403879 403878 403677 403676 403675 403674 403882 403111 403114 403113 403115 403201 403202 403204 403205 403222 403223 403807 403806 403803 403805 403540 403541 403565 403543 403568 403569 403804 404008 404009 404011 404010 404194 404195 404197 406441 406440 404012 404013 406439 406438 407859 407873 407872 407871 407858 407856 407870 407869 407868 407867 407866 407329 407328 407237 407086 407085 407084 407083 407082 407874 407236 407234 407232 407233 408571 408361 408362 408363 408364 408365 411257 411255 411254 408575 408574 408573 408572 411384 411382 411381 411390 411389 411388 411386 411385 411395 411394 411393 411392 411391 411444 411443 411442 411441 407327 411749 411748 411746 411747 411745 412014 412013 412012 412011 412010 407235 413093 413090 413089 413092 413091 412468 412469 412470 412471 412472 412361 412362 412363 412359 412360 412219 412220 412221 412222 412223 413641 413930 413644 413642 413931 413643 413640 413933 413932 413934 421238 421237 421236 421235 421234 421283 421282 421281 421280 421279 416788 416787 416786 416785 416784 421676 421675 421674 421673 421672 405963 405966 405967 405972 405969 405970 405977 405976 406331 406329 406328 406330 405435 405434 405433 405716 405717 405714 405715 404435 405437 404454 404436 404452 404453 404451 404940 404941 404942 404938 406381 406378 404939 406379 406380 405442 405441 405440 405439 405469 405947 405946 405945 405944 405603 405607 405606 405604 405712 405711 405710 405709 405708 422636 422635 422634 422633 422632 422701 422700 422699 422698 422697 422941 422940 422939 422938 422937 422476 422475 422474 422473 422472 422983 422982 422986 422985 422984 426269 426268 426265 426266 426267 426310 426311 426312 426313 426314 426571 426572 426520 426519 426518 426517 426516 426670 426671 426573 426574 426575 426672 426673 426674 426820 426821 426822 426823 426824 404748 404746 404749 404812 404914 404915 404916 404809 404808 426814 426811 426810 426812 404810 404811 404964 404963 405143 405144 426826 405145 405147 405146 404747 426806 426809 432950 432949 426368 426367 432951 432948 426880 426881 426882 426883 426884 426369 426366 426365 426818 426817 422757A 426815 426816 426819 432947 427055 427056 432963 432962 432993 432992 432996 432995 432994 422726 422725 427054 427053 427052 427021 427020 427019 427018 434270 434269 434333 434332 426899 426898 426895 426897 426896 434335 434334 434336 435880 435878 435879 435877 434702 435838 435837 435840 435839 435841 426813 435771 435768 435770 435769 435767 435855 435852 435856 435785 435786 435783 435784 435782 435790 435791 435788 435854 435853 435789 435787 435934 435932 435486 435487 435485 435591 435590 435935 435936 435933 435946 435945 435943 435944 435942 435293 435292 435291 435294 435290 435904 435906 426825 426805 426808 435592 435588 435589 435903 435902 435905 435927 435928 435929 435930 435595 435596 435597 436205 436206 436202 436203 436204 436239 436241 436238 436240 436237 437114 437113
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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