Back to search
FDAFDA · Food and drugs·Recall number Z-2954-2024

Impella CP Smart Assist Set, EU; Product Code: 0048-0014;

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: 0048-0014; UDI-DI: 04260113630280; Serial Number: 387712 384919 384920 384921 384922 384928 385851 385854 385852 384923 385855 384924 384925 384926 384927 387211 385859 385858 387208 387207 385857 385856 387209 385860 387210 387452 387453 387213 387449 387450 387451 387205 387204 387212 387206 387448 387125 387126 387129 387130 387131 387132 387444 387446 387447 387228 387225 387224 387411 387410 387409 387408 387406 387405 387407 388384 388383 388382 388380 388379 387412 388376 388375 386046 387413 388185 387886 387885 387884 388182 388181 388180 388178 388177 388176 386405 386404 386403 386402 386401 386399 386398 386396 388337 388336 388184 388183 387583 387582 387580 387579 387578 387577 387576 387575 388334 388333 388332 388331 388330 388329 388328 388327 388689 388688 388657 388656 388655 388654 388653 388651 388687 388686 388685 388683 388862 388861 388860 388859 388858 388857 388856 388855 388326 388325 388892 388985 388984 388983 388982 388707 388706 388705 388704 388703 388702 388701 388962 388961 388960 388854 388888 388887 388885 388884 388710 388709 388708 388729 388728 388727 388726 388725 388724 388723 388722 384653 384652 388890 388959 388958 388956 388955 388954 388953 388356 388355 389079 389078 389077 389076 389075 389074 389073 389072 389071 388721 387561 387562 387560 387559 387557 387558 387555 387556 388104 388105 390083 390086 388103 388102 388101 388100 388096 388097 388098 388099 390216 390215 390214 390226 390222 390221 390220 390219 390218 390217 390174 389723 389722 389721 389720 389719 389718 389717 389715 389714 390082 390079 390077 390078 390212 390211 390207 390208 390209 390210 390167 390170 389418 389417 389422 389416 389421 389573 389424 389423 387385 387384 389682 389681 389680 389679 389678 389677 389676 389675 389435 389434 389433 387393 387391 387390 387389 387388 387387 387386 389571 389570 389569 389568 389567 389566 389565 389564 389345 389623 389622 389621 389620 389619 389618 389617 389616 389615 389674 389614 389344 389343 389342 389341 389340 389339 389338 389337 389336 389432 389430 389429 389428 389427 389426 387463 387462 387461 387459 387458 387457 387456 387455 387454 389383 389384 389385 389381 389382 389380 389379 389378 389377 389049 389047 389043 388273 388272 388271 388270 388269 388268 388266 389042 389041 389391 389390 389386 389387 389388 389389 388142 388141 388139 388138 388137 388136 389395 389394 389393 389392 389713 389712 389711 389710 389709 389707 389706 389705 389704 389415 388143 389414 389413 389412 389411 389410 389409 389408 389407 389406 389624 389603 389602 389601 389600 389599 389598 389597 389596 389594 389693 389692 389633 389632 389625 389627 389628 389629 389630 389631 389690 389689 389688 389687 389686 389685 389684 389702 389701 389700 389699 389698 389697 389696 389694 390106 390101 390103 390246 390243 390244 390245 390100 390240 390242 390099 390098 390097 390116 390115 390114 390113 390112 390111 390110 390109 390107 390104 390105 390250 389605 390289 390288 390286 390285 390284 390283 390282 390281 390280 389653 389652 389650 389649 389648 389647 389645 390448 390447 390446 387574 387573 387571 387570 387569 387568 390443 390442 390441 390440 389613 389612 389611 389610 389609 389608 389607 390459 390458 390456 387566 387567 390259 387565 390257 390258 390255 390256 390252 390254 390239 390238 390237 390278 390276 390274 390273 390272 390271 390270 390488 390487 390299 390298 390297 390296 390295 390294 390421 390420 389455 389454 389453 389452 389451 389449 389448 390293 390291 390290 389447 389446 387876 387875 387874 387873 387871 387870 387869 387867 390466 390465 390463 390464 390462 390461 388115 390460 388111 388113 390480 390482 390478 390479 390477 388110 388108 388109 388106 388107 390486 390483 390484 390485 390709 390708 390707 390704 390703 390721 390720 390719 390718 390717 390715 390711 390710 390712 390714 390713 387906 387905 387902 387901 387900 387899 387898 389642 389641 389640 389638 389636 389635 389634 39
Risk classification
Class II
Area (FDA)
device
Country
United States

Sell products like this?

Recalert watches your whole catalog for recalls like this one, automatically.

Start free — no card