Recall archive / FDA device enforcement

Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; — FDA record Z-2955-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Reason: 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.
Classification: Class II
Recalling firm: Abiomed, Inc.
Quantity: 6,267 units
Agency-reported status: Ongoing
Source record identifier: Z-2955-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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 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Label field

Details supplied by the agency

Lot, code or applicability

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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414185 413950 413954 415177 415181 412777 415178 415183 415400 415401 415404 415405 415398 415399 415682 415154 393554 408732 412778 415155 415156 416127 416129 415652 415657 415660 416134 416135 415683 415686 415687 415688 415689 416126 416125 416124 416128 416130 413781 413851 414858 414864 414868 416143 416874 416875 416879 416380 416398 416188 417524 416835 414855 414857 414860 414861 415152 415149 415148 414446 414448 414867 416136 416137 416138 416139 416140 416142 416876 416878 416395 416184 416189 416190 416191 416193 414856 415147 414443 417525 417526 417527 417528 417531 417532 412365 414186 413949 415153 416374 416375 416401 417533 416834 416838 413846 412584 414445 414863 414866 414871 414872 416881 416882 416883 415427 415431 415432 415433 415434 415435 415436 416376 416381 416396 416402 416403 414869 416186 416185 417530 416837 410597 410600 408636 408401 410330 415685 416836 401148 410331 410622 412578 415151 414449 414870 415429 416378 415150 416880 416377 416394 408733 410594 408639 401142 414854 414859 416131 401152 410329 413775 413777 416132 416133 416141 416399 416187 416839 416840 416841 416843 417485 417484 417772 417773 417775 410667 416877 415430 355417 398104 417774 417776 417778 417779 417780 417781 417777 389299 410598 412581 414862 417732 417733 417734 417737 417738 417740 410690 408637 408402 415655 417741 415661 414187 415185 415186 417739 417491 417492 417489 418710 418711 418712 410689 413772 413945 417493 417930 417932 417933 417934 418704 418706 418707 418708 418709 418713 417891 403693 413773 417929 417927 417887 417888 417889 417890 402195 417892 417893 417895 418570 418572 418576 418577 417917 418575 418578 417918 410614 415184 418573 417921 417922 410833 410832 410621 417894 417919 413788 413946 418705 410830 410835 419069 419071 419072 419073 419074 419075 419076 419077 410829 410834 419613 419614 419121 419122 419123 418559 419612 419615 419617 418569 419068 417923 417925 417926 418561 418567 418568 418668 419030 418563 418564 418566 ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 11, 2024
Recall initiation date: Aug 5, 2024
Center classification date: Sep 4, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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