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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95129

18 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 05, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Abiomed, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

18 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 18

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

Z-2954-2024
Recall number
Z-2954-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
17,837 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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 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Distribution pattern

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.

device · product 2 of 18

Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;

Z-2955-2024
Recall number
Z-2955-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
6,267 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 0048-0024-JP; UDI-DI: 00813502011609; Serial Numbers: 353552 376694 381128 383037 383039 383040 383041 383042 383043 383044 383045 383046 382465 382467 382468 382469 382470 382472 382136 382138 381247A 379963A 382779 382780 382781 375895 383330 382466 382782 382784 382787 384202 384201 383804 383806 382783 383808 383809 385265 385266 385272 386835 383810 373929 381881 385218 385220 385223 385270 385219 371886 375943 382788 382789 382790 382792 382793 372575 375208 382794 382795 382796 385724 385726 385727 385728 385721 385723 374156 378689 384134 384138 384139 385526 385528 384132 376414 381123 381859 382132 381869A 382785 384140 385530 385531 382786 385532 384207 384210 384684 384687 384688 384689 384128 384692 384126 375207 382130 383813 385527 385529 385534 384123 374157 369021 379105 383811 384133 385729 385730 384693 386201 386202 386207 386209 384983 384981 384980 386032 387077 387085 370796 383812 385525 386204 386210 386033 384204 384205 384209 384685 387078 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464315 464316 464317 458214 458219 466822 466826 464320 464101 464102 464103 464104 464105 464107 464108 465057 465059 458220 464319 460058 445419 445424 445426 464106 464110 465058 465060 434828A 391005 418574 457786 464318 445428 466847 466849 466852 466853 466854 467905 467906 467907 467908 467910 467911 467913 466861 466862 466863 466866 466868 445427 467915 466830 466869 466591 466592 466593 466595 466597 466598 466529 466530 466531 466533 467895 467909 467914 466865 464329 466534 467847 466594 466535 466538 444461 467849 467850 467852 467854 469226 469229 443751 466590 466596 467896 467846 467848 469223 469224 432720 464327 464328 469232 467902 467903 467916 467917 467918 467922 467923 467924 467853 469225 460063 466855 466864 459841 459843 459844 459846 459847 459848 469113 464333 461953 469228 467901 467904 467919 467921 466537 467899 469114 462883 467845 459840 462884 462885 462886 462887 462888 462889 462900 462902 466532 457585 462904 462906 462908 462909 469083 469084 469085 462901 462905 462907 457787 469087 469088 469090 469393 469394 469399 469400 469401 469402 469386 462903 469086 469387 469388 469390 469391 469392 469116 469117 469119 469120 469089 469091 469395 469396 469397 469398 470855 470860 471046 471048 471049 471051 471064 471067 470843 469389 469115 469118 469122 470852 457138 470844 470850 470851 470913 470916 470917 470920 471042 471043 459849 470848 465481 465485 465487 465488 472277 472280 460100 470846 470915 470919 471069 471071 460060 413601 460106 460107 460109 465496 465501 465503 465504 468066 468068 468069 468072 468074 465104 465486 465489 465490 460101 461667 465107 465108 465109 465110 465072 465073 465074 465079 465081 465497 468070 468071 465102 469182 469181 469180 469178 470932 471053 471055 471056 471057 471059 465106 432721 471068 468096 468098 468101 469185 469186 469373 462881 469179 471061 472335 472336 472339 471058 469187 454744 460053 465105 468099 469377 469380 472333 472340 472341 472281 472284 472285 472291 472293 472294 472296 470935 466850 472334 468095 470939 470940 473249 473250 473254 472249 472251 472397 472398 472403 472404 472405 472263 468065 469376 469379 472286 472287 472290 472292 472295 470933 471063 468073 469378 472406 472259 472266 471601 469381 472332 473247 473248 472250 472264 471044 471602 471606 473912 473913 473915 470849 472402 470842 465499 469183 473438 473264 473229 473274 473441 473916 465505 471597 424679 473439 473436 473261 473262 473230 473233 473266 473267 473271 473275 471598 471600 472278 465502 473226 473228 473231 473232 473272 436730 470847 470914 465484 471052 468097 468100 473440 473437 473234 473235 471599 472283 472289 462892 473442 473443 473445 460104 471054 471588 467897 473246 473253 471587 462893 462894 472288 470941 462899 461987 462896 462897 462898 473497 473501 470938 462890 462895 473498 473502 473504 470934 473251 472400 472261 472262 473478 473480 473482 473483 473484 473485 473227 473270 445248A 464092 464094 464095 464098 470936 473499 473257 472260 472265 473258 473259 473263 465066 472248 472245 472243 472258 473505 473479 472242 471577 471578 471579 471581 471584 471585 471589 471591 471594 473255 465061 465062 465065 471590 471592 465078 470937 464097 464099 464100 471595 471596 473461 473464 473465 473467 473468 473470 474802 474803 474807 474808 474809 471580 471582 461668 466829 473496 465064 474810 474811 444669A 473917 473919 473920 470854 470857 470861 475138 475137 473930 476321 476320 476516 471593 473466 466870 476324 476517 475156 475158 475161 475163 475165 476274 476273 476271 476270 476290 476291 476292 476330 476332 475136 473931 476323 476322 476515 476335 476337 476338 474798 474799 474800 474801 476277 476278 476279 477648 477650 477651 477653 477655 477656 476518 475162 475164 476295 476296 476331 442932A 443303A 476511 476513 477657 476485 474796 477652 379965 471045 443152A 473926 475174 475175 475148 475151 475155 475139 475141 475145 475181 476514 473928 471583 475149 476510 473477 475173 476328 475150 475140 475183 475185 475186 475187 475188 475189 475190 476489 476490 476491 476493 473273 475170 475171 475172 476329 475147 476492 464096 476563 476564 474795 476325 477649 477624 477622 477621 477626 477676 475168 476560 476562 476565 477623 477620 477619 477618 422286 462891 464091 465063 471603 476566 476567 476568 474794 474792 476327 476326 477675 477673 477672 477670 477628 408753 476569 477674 477669 465075 477668 477631 477632 477633 477634 477635 477636 477637 477658 477659 474797 477671 477630 477660 401126 476488 477662 477663 477665 477666 477667 477608 477661 477664 477610 477617 465472 465473 465474 477888 477889 477890 477896 477897 479289 479290 479292 479294 479296 479297 479298 445702A 477677 465469 476275 479319 477893 477894 479291 479295 473922 476276 465467 479280 479282 479283 479284 479285 479286 478181 478182 478183 478189 465468 479288 478186 478188 473924 473925 475144 477892 479293 479239 479241 479242 479243 479244 481139 476561 476519 465466 478190 479245 479248 479320 479321 479324 479325 479246 479247 472413 472412 479327 470871 470870 470868 470867 472414 479326 479328 470874 472415 466541 472416 472419 472420 472421 466542 466543 466545 466546 466547 462871 462872 462874 472417 466539 466540 466544 473923 475154 478184 462876 462878 462879 480774 480777 480778 480779 480781 477615 462875 480775 480776 480780 480782 480790 480791 480788 480789 462877 480786 469374 480784 480785 477900 477905 477906 477907 479301 479302 479304 479307 480792 482257 482258 482259 482261 482262 480980 480981 480986 480987 480787 480793 480988 465080 476486 481021 481022 481025 481027 481142 481143 481145 481147 480761 480811 480809 480805 482237 482242 482243 482244 482245 482050 482051 482052 481028 480806 480804 482238 482240 482049 469375 482053 482055 482056 482253 482252 482249 482247 482092 482094 482096 482100 482263 464298 483463 483464 477902 479306 481023 481140 464299 483465 483466 483467 483468 483469 481123 464295 482077 482080 482081 482090 482088 482087 482085 482082 481115 481118 482089 483471 483737 479490 479489 482255 483689 483688 483687 483686 483685 483684 483712 483715 483717 477629 479273 479439 472244 473469 476487 481141 473927 470875 481144 479440 479441 479442 479443 479444 483733 481069 481074 481075 466589 482038 481071 481072 426296 479450 479453 479455 479456 479483 480764 480769 480755 480757 482072 482076 483735 483736 483711 482037 482041 479451 479452 479454 480765 480766 483709 483750 483747 479475 479477 479269 479271 479277 479445 479446 479447 479448 479449 479457 479479 479480 480768 480770 480771 483710 483745 479275

Distribution pattern

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.

device · product 3 of 18

Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;

Z-2956-2024
Recall number
Z-2956-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 0048-0034-JP; UDI-DI: 00813502011463; Serial Numbers: 324303 323153 328083 328085; Batch Numbers: 2022079852 2022079846 2022083745 2022083747

Distribution pattern

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.

device · product 4 of 18

Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;

Z-2957-2024
Recall number
Z-2957-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 0048-0040; UDI-DI: 00813502011739; Serial Numbers: 370089 370091 370090 370074 370093 401804 401805 401811 401806; Batch Numbers: 2023172492 2023172497 2023172494 2023172500 2023172499 2023255511 2023255513 2023255522 2023255514

Distribution pattern

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.

device · product 5 of 18

Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;

Z-2958-2024
Recall number
Z-2958-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
323 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 0048-0044; UDI-DI: 00813502012200; Serial Numbers: 383487 383488 383489 381637 381777 381640 381639 381638 379660 379659 379661 372534 372535 386882 389812 389809 389811 389814 389813 386881 386879 386880 386943 388495 388498 391472 391470 391471 387330 387329 387333 387332 387331 389489 389493 389491 389490 389492 387328 388467 388465 388527 388528 388469 388470 388471 386005 386001 386008 386006 386007 386004 386170 386168 386169 386003 385999 386009 385933 385931 385921 386000 385938 385939 385940 385923 385922 386010 385935 385937 385934 390915 390914 390913 390912 392642 392643 392644 392534 392535 392537 392538 392640 392641 392536 392835 392834 392829 392828 392903 392902 392836 392837 392833 392906 392824 392831 392830 392826 392825 393083 393082 393079 393080 393081 427384 427383 427382 427381 427379 428638 428639 428640 428630 428641 428642 428631 428629 428623 428632 429793 429780 429794 429784 429786 429787 429788 430901 429789 428645 428646 429770 431699 431702 431700 431701 431695 430897 430898 430899 433880 429771 433881 431694 431696 431698 430900 430904 430903 430902 429792 429785 429782 429797 429791 429790 435973 435975 435974 435976 435149 435152 435150 435151 435148 438046 438047 438045 438040 438041 438042 438043 438044 438048 438694 445510 445509 445514 445513 445517 445511 436001 445516 436000 435999 451167 445521 445550 445557 451173 453374 453376 453368 453236 450524 451168 450521 450541 445520 445527 450520 445524 445518 445519 445526 445525 455398 455397 455394 450518 450519 450523 454032 445549 445554 453427 453425 453231 453155 453230 453158 453426 453428 453154 453153 453369 453237 453235 453375 453373 453228 453157 453156 453370 453371 453372 453229 453234 453377 453232 445555 453233 445551 445552 451165 431647 431648 453971 453572 453571 451172 451656 452098 450544 451166 451171 452082 452083 451724 451662 451657 451725 453972 453570 455396 453424 454033 454035 453967 452099 452103 451723 453966 452076 453968 452081 454029 454037 454030 454031 454034 453974 453567 453573 445553 453569 452077 486295 486271 486272 486273 478008A 486259 486296 486270 486274 486276 486277 486278 486279 474327 474328 486275 474329 474330 474331 487612 487613 487614 487615 487616 493536 493537 493538 493539 493540 493541 493542 493544 493545 489740 489743 493546; Batch Numbers: 2023212081 2023212080 2023212079 2023206026 2023206024 2023206029 2023206028 2023206027 2023204432 2023204428 2023204436 2023204441 2023204447 2023222485 2023227971 2023227974 2023227973 2023227964 2023227968 2023222483 2023222479 2023222481 2023222478 2023233647 2023233646 2023233656 2023233652 2023233654 2023248877 2023248873 2023248885 2023248882 2023248880 2023236762 2023236770 2023236766 2023236764 2023236769 2023252334 2023252332 2023252331 2023256979 2023256976 2023256973 2023256974 2023256975 2023266986 2023266989 2023266975 2023266979 2023266981 2023266983 2023266996 2023266993 2023266995 2023266991 2023268388 2023268395 2023268409 2023268407 2023268406 2023268391 2023268420 2023268422 2023268423 2023268401 2023268404 2023268398 2023268413 2023268418 2023268412 2023282144 2023282137 2023282127 2023282121 2024285344 2024285345 2024285347 2024285349 2024285351 2024285354 2024285357 2024285340 2024285342 2024285353 2024295406 2024295404 2024295422 2024295417 2024295385 2024295388 2024295415 2024295394 2024295402 2024295391 2024295432 2024295427 2024295425 2024295435 2024295434 2024306035 2024306040 2024306052 2024306049 2024306043 2024311479 2024311482 2024311484 2024311486 2024311489 2024315119 2024315124 2024315129 2024315159 2024315131 2024315143 2024315163 2024315158 2024315171 2024315167 2024319237 2024319251 2024319249 2024319266 2024319268 2024319271 2024319274 2024328109 2024319275 2024319277 2024319280 2024331031 2024331045 2024331051 2024331047 2024331049 2024331038 2024338407 2024338424 2024338432 2024338436 2024331020 2024338439 2024331035 2024331041 2024331044 2024328106 2024328120 2024328117 2024328113 2024342709 2024342716 2024342715 2024342708 2024342714 2024342712 2024342717 2024342719 2024342718 2024342720 2024355494 2024355482 2024355492 2024355490 2024355497 2024365370 2024365372 2024365360 2024365346 2024365349 2024365352 2024365354 2024365356 2024365376 2024365379 2024371719 2024371722 2024371711 2024371713 2024371707 2024371716 2024371699 2024371703 2024371697 2024371696 2024377459 2024377420 2024377421 2024377423 2024377466 2024378541 2024378543 2024378548 2024378550 2024374379 2024377463 2024374376 2024375071 2024374343 2024374351 2024374374 2024374345 2024374362 2024374341 2024374349 2024374347 2024380603 2024380606 2024380617 2024374370 2024374372 2024374378 2024380639 2024375087 2024375093 2024378526 2024378528 2024378555 2024378532 2024378556 2024378529 2024378527 2024378524 2024378533 2024378534 2024378547 2024378549 2024378551 2024378542 2024378540 2024378558 2024378530 2024378531 2024378535 2024378538 2024378539 2024378557 2024378552 2024378546 2024378554 2024375095 2024378553 2024375088 2024375089 2024377457 2024377431 2024377430 2024380682 2024380704 2024380702 2024377465 2024374323 2024375101 2024375083 2024377458 2024377464 2024377452 2024377454 2024375147 2024374335 2024374325 2024375149 2024380685 2024380700 2024380609 2024380631 2024380645 2024380648 2024380665 2024375104 2024375133 2024375145 2024380658 2024377433 2024380668 2024377450 2024380633 2024380651 2024380636 2024380638 2024380646 2024380688 2024380691 2024380706 2024375090 2024380693 2024377440 2025495546 2025495553 2025495556 2025495559 2025495538 2025495540 2025495544 2025495549 2025495564 2025495572 2025495575 2025495578 2025495580 2025495585 2025495619 2025495570 2025495620 2025495621 2025495622 2025505201 2025505205 2025505208 2025505210 2025505212 2025517258 2025517259 2025517261 2025517263 2025517265 2025517266 2025517267 2025517268 2025517269 2025517271 2025517283 2025517284;

Distribution pattern

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.

device · product 6 of 18

Pump 371 14F LT CMR Set; Product Code: 0048-0045;

Z-2959-2024
Recall number
Z-2959-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
43,636 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 0048-0045; UDI-DI: 00813502011876; Serial Numbers: 381707 379142 384464 378824 378853 383418 384433 382733 384889 382279 384890 382280 384814 382281 384815 382282 382283 384816 384817 382284 384624 384625 382286 384818 384819 384820 384821 384822 384823 383689 382734 382735 383684 382736 382737 383686 382738 382739 383687 382740 383688 382741 383744 382742 383745 383520 383746 383521 383747 383522 383748 383749 383750 383751 383752 383753 383523 384891 383524 384892 382287 383525 383526 384893 381601 383527 381602 384894 383529 381604 384895 381605 384896 381606 381607 384897 381608 384898 381609 383798 381610 383799 383801 381325 383800 383802 381326 383803 381327 381566 381567 381568 381569 381571 381572 381573 381574 381575 383017 383291 383292 383293 383294 383295 383296 383297 383298 383299 383300 383251 383254 383256 383257 383258 383260 383261 383262 383264 383266 383267 383268 383269 383690 383691 383692 383693 383026 383241 383244 383245 383247 383248 383249 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Distribution pattern

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.

device · product 7 of 18

Impella CP Smart Assist Set APAC; Product Code: 0048-0047;

Z-2960-2024
Recall number
Z-2960-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
705 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 0048-0047; UDI-DI: 00813502011944; Serial Numbers: 388777 388778 388780 388893 388894 384779 384780 384781 384782 384783 383447 383448 383449 384706 384705 376210 376213 376214 376215 376216 376217 376219 387222 387223 385821 385822 385823 385824 385825 385826 385827 385828 385829 385830 386077 386078 386079 386080 386081 386082 386083 386085 386084 386181 386182 386183 386184 386185 386186 386187 386188 386190 387467 387468 386963 386959 386960 386955 386956 386953 391935 391936 391937 391938 391940 391941 391942 391943 391944 391895 391897 391898 391899 391900 391901 391902 391904 391958 377480 377481 377482 388499 388500 388501 388502 388503 388504 391960 391959 391955 389486 389487 389488 389960 389495 389496 389498 389500 389501 389502 391957 391956 389959 389961 389963 387324 387326 392163 392164 392165 392166 392167 392169 392170 389964 389965 389967 389968 387325 387327 392162 392168 389966 388468 389527 389530 389531 389532 389533 389504 389505 389506 389507 389508 389509 389512 389513 388530 388529 388532 388531 388533 386163 386162 386161 389524 388534 389525 389526 389528 388525A 386165 389539A 386166 386167 386002A 385930A 385997A 385927 390907 390908 386164 385924 385925 385928 385929 390909 390910 390911 392393 392394 392395 392396 392397 392398 392400 392401 392533 389515 389516 389517 389518 392532 392531 392530 389514 389519 389520 389521 389522 389523 392821 392822 392823 392477 392478 392479 392481 392483 392484 392485 392486 392858 392859 392860 392861 392862 392863 392864 392865 392866 392856 392857 392808 392811 392812 392813 392816 392817 392645 392646 392648 392647 392818 392820 392867 392762 392759 391836 392761 392760 392758 391835 391837 391838 391839 391830 391833 391831 391834 392889 392888 393086 393087 393084 393085 392905 392907 392900 392898 392899 392883 392881 392886 392901 392880 392884 392885 392887 392819 392890 392896 392897 392895 392894 392893 392892 392891 393078 427408 427404 427403 427397 427395 427396 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495352 495353; Batch Numbers: 2023218526 2023218529 2023218532 2023218539 2023218547 2023219943 2023219945 2023219947 2023219958 2023219961 2023219966 2023219970 2023219973 2023219976 2023219978 2023222346 2023222353 2023222368 2023222372 2023222373 2023222375 2023222380 2023224158 2023224163 2023224164 2023224165 2023224166 2023224167 2023224168 2023224169 2023224170 2023224171 2023224175 2023224176 2023224177 2023224179 2023224181 2023224183 2023224184 2023224185 2023224186 2023224187 2023224188 2023224189 2023224190 2023224191 2023224192 2023224193 2023224194 2023224195 2023224196 2023224198 2023224320 2023224324 2023225262 2023225265 2023225266 2023225267 2023225269 2023225271 2023229105 2023229107 2023229111 2023229114 2023229119 2023229126 2023229131 2023229135 2023229138 2023229141 2023229142 2023229144 2023229146 2023229153 2023229156 2023229160 2023229161 2023229170 2023232426 2023232427 2023232428 2023233696 2023233705 2023233708 2023233710 2023233711 2023233712 2023229166 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Distribution pattern

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.

device · product 8 of 18

Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;

Z-2961-2024
Recall number
Z-2961-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
1,889 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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 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2025447617 2025447618 2025447619 2025448365 2025448367 2025448368 2025448369 2025448370 2025448371 2025448373 2025448378 2025448379 2025448381 2025448388 2025448390 2025448394 2025448396 2025448397 2025448401 2025448403 2025448404 2025448405 2025448406 2025448410 2025448413 2025448414 2025448418 2025448419 2025448420 2025448421 2025448423 2025448425 2025448426 2025448433 2025448434 2025448435 2025448436 2025448437 2025448438 2025448443 2025448444 2025448446 2025448448 2025452917 2025452918 2025452921 2025452922 2025452923 2025452924 2025452926 2025452927 2025452930 2025452932 2025453418 2025453419 20

Distribution pattern

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.

device · product 9 of 18

Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;

Z-2962-2024
Recall number
Z-2962-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 0550-0004; UDI-DI: 00813502010466; Serial Numbers: 439898 437211A 437204A 440938 439938 439939 453784 453785 476355 476356 470678 493496 493497 491749 491752 491751 478569A 483483A 491750 485277A 485281A; Batch Numbers: 2024337828 2024338391 2024338394 2024340273 2024341579 2024341586 2024356969 2024356971 2024397878 2024397886 2024399646 2025440057 2025440061 2025448005 2025452639 2025452668 2025484262 2025484276 2025448006 2025500661 2025500668;

Distribution pattern

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.

device · product 10 of 18

Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;

Z-2963-2024
Recall number
Z-2963-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
2,916 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 0550-0008; UDI-DI: 00813502011531; Serial Numbers: 387019 388061 388062 388063 388064 388065 387273 388067 388068 387339 387340 387341 387342 387343 388071 388072 388073 388074 388075 388057 388058 388060 387319 387320 387321 387322 387323 383456 383457 383458 388084 383742 383731 384086 387304 387306 387307 387308 383455 383459 388081 388082 388083 388085 388076 388077 388078 388080 384031 384032 384033 384034 384035 383739 383741 383743 383729 383730 388311 388312 388301 388302 388307 383681 388605 388606 388607 388608 388286 388287 388288 388289 388295 388296 388297 388298 388299 388310 388313 388314 388290 388291 388293 388300 388304 388305 388306 388308 388309 389151 389152 388609 388624 388625 389117 389120 388619 388618 388617 388616 388615 388611 388612 388614 389116 389118 389119 389101 389102 389103 389104 389105 388626 388627 388628 388629 388630 388610 388613 389153 389154 389155 389320 389319 389318 389317 389316 389161 389163 389164 389753 389312 389306 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Distribution pattern

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.

device · product 11 of 18

Pump 381 Pump Set (US); Product Code: 1000080;

Z-2964-2024
Recall number
Z-2964-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
11,236 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 1000080; UDI-DI: 00813502012279; Serial Numbers: 411717 411718 411715 411716 411720 411721 411722 411723 411724 411705 411706 411707 411711 411712 411719 411814 411813 411812 411811 411810 411809 411708 411709 411710 411713 411714 411808 411807 411806 411805 411866 411867 412111 412112 412142 412143 412110 412113 412114 412115 412116 412117 412141 412000 412148 412146 412144 412145 412140 412147 412001 412003 411860 411861 411862 411863 411864 412004 412005 411321 411477 411473 411474 411310 411890 411889 411888 411887 411475 411476 411468 411467 411469 411470 411301 411478 411461 411462 411463 411464 411465 411472 411303 411304 411309 411466 411302 411305 411306 411307 411892 411893 411894 411895 411896 412461 412463 412465 412301 412330 412331 412332 412333 412334 412335 412336 412337 412338 411891 412467 412149 412299 412300 412303 412304 412305 412308 412329 412459 412458 412460 412462 412464 412306 412307 411546 411547 411549 411550 411733 411855 412888 412889 412890 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Distribution pattern

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.

device · product 12 of 18

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

Z-2965-2024
Recall number
Z-2965-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
11,576 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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 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Distribution pattern

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.

device · product 13 of 18

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

Z-2966-2024
Recall number
Z-2966-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
788 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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 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2024409945 2024409965 2024414126 2024417423 2024417443 2024417439 2024402484 2024417451 2024407748 2024417453 2024417467 2024417464 2024417465 2024417469 2024414121 2024414149 2024417430 2024417472 2024417474 2024417433 2024417471 2024421052 2024421049 2024421056 2024421059 2024421087 2024407355 2024421060 2024421068 2024421080 2024421090 2024421092 2024410010 2024421097 2024407756 2024424658 2024424665 2024424666 2024424668 2024424672 2024407798 2024409987 2024424673 2024424676 2024414136 2024424659 2024417446 2024421102 2024424664 2024433865 2024407762 2024421111 2024409948 2024414145 2024433866 2024433888 2024385537 2024410020 2024393903 2024414143 2024421129 2024424695 2024433884 2024424677 2025441737 2024421132 2024417473 2024421108 2025441760 2024417480 2024414150 2024433877 2024417442 2024424694 2025441765 2024407768 2024409952 2024433862 2025441733 2024424640 2024433869 2024433882 2025441697 2024421030 2024433874 2024424654 2024398495 2024414125 2024424693 2024410017 2024409974 2025441767 2024421135 2025441797 2024424667 2024392877 2024407739 2024409959 2024421116 2024409962 2024410002 2024424656 2024409920 2024414142 2024410007 2024424670 2025441728 2024421104 2024410015 2024424681 2024379656 2024385521 2024409995 2024407803 2025441793 2025441794 2024414118;

Distribution pattern

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.

device · product 14 of 18

ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

Z-2967-2024
Recall number
Z-2967-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 1000302; UDI-DI: 00813502012767; Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669; Batch Numbers: 2023263121 2023263124 2023263125 2023269641 2023269670 2023269672 2023269673 2023269674;

Distribution pattern

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.

device · product 15 of 18

Impella 5.5 Set AU; Product Code: 1000361;

Z-2968-2024
Recall number
Z-2968-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 1000361; UDI-DI: 00813502012927; Serial Numbers: 425570 425332 425331 463954 463955 476358 476357 481131 481130 481129 485279 485278 485280 480079 483437 466172A 491829 491830 491831 491832; Batch Numbers: 2024286281 2024286289 2024286292 2024375505 2024375511 2024398832 2024398833 2024413728 2024413879 2024413882 2024431078 2024431158 2024431171 2024431175 2024431650 2024431652 2024431653 2024431656 2024431673 2024431720;

Distribution pattern

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.

device · product 16 of 18

Impella CP Smart Assist Set; Product Code: 1000402;

Z-2969-2024
Recall number
Z-2969-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 1000402; UDI-DI: 00813502012873; Serial Numbers: 385946 385942 385944 385945 385950 385941 385949 385947 385948 385943 392855 392853 392854 392852 392851 392848 392849 392879 392878 427388 427387 427386 430896 430875 430874 430873 430872 430871 430870 430869 430868 430867 431652 430895 430894 486297 486298 486299 486300; Batch Numbers: 2023251705 2023251861 2023251862 2023251869 2023251872 2023251874 2023251876 2023251879 2023251881 2023251902 2023283187 2023283192 2023283194 2023283196 2023283200 2023283208 2023283216 2024305462 2024305463 2024305465 2024305466 2024305467 2024308137 2024308138 2024308139 2024308141 2024308143 2024308144 2024308146 2024308148 2024308149 2024308150 2024308159 2024308160 2024308162 2025501277 2025501292 2025501297 2025501301;

Distribution pattern

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.

device · product 17 of 18

Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;

Z-2970-2024
Recall number
Z-2970-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
286 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Code: 1000459; UDI-DI: 00813502013054; Serial Numbers: 491248 491249 491975 491974 490744 491976 491977 490747 490725 490739 490740 490741 490742 490743 490727 491252 491239 491253 491235 491241 492012 490724 492009 491246 492005 492010 492011 491981 491240 491243 493477 491982 493476 493478 493480 493479 492004 490745 494684 494686 494687 493837 493838 493839 494689 494688 494690 494691 494692 494693 490746 494734 491236 494736 493836 494735 499143 494737 494738 491242 493840 492013 499157 499148 499156 491237 491978 494743 499153 499144 501038 501071 499155 499150 501132 499154 490728 499152 499168 501040 499738 499744 499170 501183 499740 499739 499741 501186 501041 499743 499746 501093 501205 492008 499742 501097 501094 501128 501129 501130 501184 501131 501054 491245 501204 504904 501039 501057 499147 501069 501070 501207 501213 501215 501187 498548 491238 498549 498930 501217 501072 501206 504888 491979 507422 504890 494740 504891 504893 501042 499745 499747 501056 501185 505122 507318 505123 504909 498552 498929 504913 504907 490748 494739 504879 507414 506589 504882 504883 505889 492007 504885 505890 494742 498928 501203 504905 498945 498943 498949 499145 501214 507371 507372 507315 507317 498946 506590 498550 506591 506592 498964 504884 498965 498966 498931 498973 498967 504908 498974 498975 498944 498977 506607 498950 498952 498963 498551 498553 507383 498555 498556 506606 507369 498557 504889 505121 504880 498932 498968 498554 504911 498972 506593 498969 507380 507379 498976 507418 507420 509243 501216 509247 509244 498970 505120 509246 509231 509232 509289 509245 504910 504906 509230 507373 507316 507381 509199 498971 509202 505891 509228 509288 511242 511241 509291 512372 504912 507314 511259 511260 511261 511262 512373 507416 507417 511239 511275 509163 509166 509164 512924 505892 501053 504886 512927 512928 512939 507419 498947 498948 507370 512942 512943 511240 509167 511279 511280 505119 511263 512371 511282 507382 509198 512940 512966 511243 511283 511274 512967 512968 507423 511276 513195 513196 513198; Batch Numbers: 2024434436 2024434438 2025437468 2025437135 2025441891 2025437471 2025437477 2025441898 2024434429 2025437487 2025437489 2025437490 2025437491 2025437496 2024434430 2025437499 2025437511 2025437503 2024434412 2025437523 2025437567 2024434426 2025437535 2024434435 2025441844 2025437547 2025437564 2025437612 2025437521 2025437531 2025441826 2025437613 2025441819 2025441831 2025441838 2025441834 2025441841 2025441893 2025444069 2025444070 2025444072 2025444134 2025444137 2025444224 2025444074 2025444073 2025444075 2025444091 2025444103 2025444108 2025441895 2025444113 2024434420 2025444122 2025444133 2025444120 2025455128 2025444126 2025444128 2025437525 2025444226 2025437594 2025455115 2025455119 2025455101 2024434421 2025437483 2025444241 2025454400 2025455130 2025459792 2025459845 2025455100 2025455121 2025459821 2025455097 2024434431 2025455124 2025455136 2025459797 2025459770 2025459823 2025455140 2025458975 2025459781 2025459775 2025459786 2025459944 2025459800 2025459822 2025459827 2025459806 2025459932 2025441890 2025459789 2025459812 2025459809 2025459814 2025459815 2025459817 2025459766 2025459818 2025459832 2024434433 2025459931 2025469865 2025459794 2025459837 2025455134 2025459838 2025459840 2025459936 2025459937 2025459939 2025459946 2025449406 2024434424 2025449532 2025449543 2025459942 2025459862 2025459935 2025466151 2025437599 2025471896 2025466038 2025444234 2025466039 2025466042 2025459803 2025459826 2025459829 2025459836 2025459943 2025466055 2025471889 2025466064 2025466069 2025449537 2025449540 2025466089 2025469879 2025441900 2025444232 2025469941 2025471890 2025469881 2025470020 2025470021 2025470022 2025441888 2025466140 2025470046 2025444239 2025449538 2025459926 2025469867 2025451117 2025451113 2025451126 2025455132 2025459938 2025471861 2025471864 2025471875 2025471887 2025451118 2025469934 2025449534 2025469936 2025469937 2025452562 2025466093 2025452565 2025452567 2025449546 2025452569 2025452568 2025470297 2025452570 2025452574 2025451114 2025452579 2025470067 2025451159 2025451163 2025452551 2025449536 2025452582 2025471840 2025452585 2025452587 2025470069 2025471856 2025452588 2025466014 2025466050 2025469996 2025449551 2025452592 2025452584 2025466083 2025452605 2025469940 2025452595 2025471836 2025471835 2025452577 2025471893 2025471895 2025477614 2025459940 2025477628 2025477620 2025452598 2025466047 2025477623 2025477644 2025477651 2025477661 2025477622 2025466078 2025469870 2025477641 2025471867 2025471885 2025471837 2025477674 2025452602 2025477676 2025470047 2025477638 2025477655 2025481034 2025481022 2025477663 2025481070 2025466086 2025471868 2025481083 2025481088 2025481096 2025481106 2025481076 2025471891 2025471892 2025481009 2025481118 2025481162 2025481186 2025481173 2025486381 2025470066 2025459830 2025466145 2025486416 2025486420 2025486423 2025471894 2025451122 2025451124 2025471859 2025486437 2025486441 2025481019 2025481198 2025489120 2025489128 2025466044 2025481113 2025481053 2025489135 2025471839 2025477671 2025486428 2025489165 2025481038 2025489139 2025481116 2025489177 2025489185 2025471897 2025481123 2025489200 2025489208 2025489306;

Distribution pattern

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.

device · product 18 of 18

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

Z-2971-2024
Recall number
Z-2971-2024
Initiated
August 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
413 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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; 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Distribution pattern

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.