FDAFDA · Food and drugs·Recall number Z-2955-2024
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
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: 0048-0024-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 387079 387081 387082 387083 385271 385274 386845 386848 386850 386851 386846 384127 386026 386837 386839 384984 386853 386836 386838 384987 384988 386841 386843 378895 386840 378894 382464 385722 386203 386030 385268 385269 385273 386834 378896 378900 378901 378902 379404 378903 388236 388237 388238 388239 388242 388243 388245 382454 382455 382457 382458 382459 388241 388244 382460 384729 384730 384732 384733 384734 384735 384737 384738 387814 387813 387801 387799 387798 387797 387796 387793 387792 387811 387810 387808 387807 387806 387795 387794 387809 384979 387805 387803 387802 388919 388922 388921 387804 388917 384137 388920 388916 387817 387819 387815 387816 387818 385533 384203 384686 387086 387800 384208 388918 384206 386205 386206 386029 387820 388026 388028 388029 388033 389185 389184 387821 384124 386028 385217 388027 389183 389181 389180 389179 389178 389546 389177 389176 389544 385215 389545 389547 389548 389552 389553 388913 389909 383560 383562 383563 383564 383569 383565 383566 386031 383568 390165 390163 390161 390160 390158 390177 390178 390179 390180 390182 390183 390159 390184 390185 390186 389919 389920 389922 389925 389926 361125 389549 389550 389551 390181 389927 389910 389912 389913 389916 389917 389918 390351 388914 390164 389921 390352 390353 390355 390357 390359 390166 390592 390595 390597 390598 390600 390601 390594 390599 391270 391271 388039 388040 388933 388934 388937 388938 388939 388941 388942 388935 388936 384135 388045 389186 389188 389189 389191 389195 391272 391273 391274 391275 391277 391279 389267 389269 389272 388035 389190 389194 391278 389270 388595 388602 389274 389275 391251 391252 391253 391254 391256 391257 388043 384690 390593 388596 391258 391450 391452 391454 391453 388603 391276 391458 391002 391003 391004 388598 391455 391006 391007 391008 391009 391010 391011 389296 389297 392778 392779 389300 391750 391751 391754 391755 391757 391758 392274 392275 392278 392281 392580 392581 392583 392582 392588 392589 392540 392542 392549 393544 393546 393547 392784 392585 392587 392546 387084 382471A 393548 393549 393550 393551 392780 392781 384122 392783 392786 392787 393553 393560 393561 393555 393556 393557 362023 393562 393285 393286 393287 393283 393284 393290 394326 394324 394323 392293 392294 392295 392296 392298 393577 393579 392300 392301 393573 393575 393580 393581 393582 393563 393565 388597 389298 391753 391759 392543 393545 393291 393568 356725 393569 393571 393567A 394331 394172 394176 394178 394179 393973 394332 394173 394175 393974 393975 393971 393978 393979 393980 391064 391066 391067 391068 391069 391060 392299 394327 367403 367806 380249 394321 392292 393564 393566 393570 394334 394181 382462 394180 393972 394329 395076 395077 394580 394328 394330 395074 394584 394585 394586 394588 394589 395067 394581 394582 394583 394587 395064 395066 395068 395070 395071 391457 395072 395073 394753 394755 394756 394759 394335 394339 394340 396235 394751 394336 394177 396237 395396 395398 395401 396236 395397
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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