FDAFDA · Food and drugs·Recall number Z-2959-2024
Pump 371 14F LT CMR Set; Product Code: 0048-0045;
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: 0048-0045; 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 383250 382395 383252 383253 384954 384953 384952 384951 384950 384949 383019 383020 383021 383022 383023 383024 383025 384579 384580 383242 384581 383243 384582 384583 383246 384585 384586 384587 384588 384959 384899 384900 384901 384903 384904 384960 384907 384961 384962 384963 384964 384965 384966 384967 384968 384363 384364 384365 384366 384367 384368 384955 384956 384957 384958 383828 384171 383829 384172 384173 384174 384175 375965 384176 375967 375968 384177 375969 375970 384178 375971 384179 384180 384211 384212 384213 384214 384215 384217 384218 384219 384220 384231 384232 384233 384234 384235 375973 384236 384237 383945 375974 383946 383942 383948 383941 383950 380075 374496 384141 384143 384144 384145 384146 384147 384148 384149 384150 383824 383825 383827 383830 375576A 381545 375966 375972 383944 380589 380590 380592 380586 380588 380584 380585 380076 380079 380080 380081 380082 380083 380084 380320 380321 380322 380323 380324 380325 380326 380327 380329 380909 380910 380911 382839 380912 382840 382841 380913 382842 380914 382843 383101 382844 383102 382845 380915 382846 383103 380916 382847 381646 381647 380917 381648 381649 381650 383104 383105 381651 383374 381653 383375 381654 381655 383377 382601 383378 382602 383379 382603 383380 382604 383386 382605 383385 383384 383383 383382 382606 382607 382609 382610 385001 385005 384504 384506 383381 384508 382838 382848 382849 382850 382851 382852 382854 383097 383098 383099 383106 383373 383376 384305 384304 384303 384443 384302 384301 384444 384369 384445 384370 384446 384371 384447 384372 384448 384999 384449 385000 384450 384451 385002 384452 385003 385004 383416 383417 383420 385006 383422 385007 383423 385008 383424 384500 384501 384502 384459 384503 384460 384461 384505 384462 384463 384238 384468 384239 384466 384240 384467 383387 383388 383389 383390 384259 384260 384042 384041 384040 384039 384038 384037 384306 384310 384111 384112 384113 384114 384115 384116 384117 384118 384119 384120 384076 384077 384080 384082 384083 384085 383477 383482 383483 383484 384036 384308 384309 384078 384079 384081 384012 384013 384014 383991 383992 383993 383994 383995 383997 383998 383999 384000 379577 379580 379581 379582 379583 379584 379585 379586 381843 381844 381845 381846 382754 382755 382757 382758 382759 382760 382761 382762 384839 384840 384841 384842 384844 384845 384846 384847 384848 383476 383478 383479 383480 383481 384934 384936 384937 384969 384973 384974 384975 384976 384977 384939 384940 384941 384943 384945 384946 384948 385195 385197 385200 385201 383719 383720 383721 383722 383723 383724 383725 383726 383727 383728 384860 384861 384862 384863 384864 384865 384866 384867 384868 383027 383028 383029 383031 383032 383033 383035 383036 384929 384930 384931 384935 384938 384971 384972 384947 385198 385199 385202 384570 384571 384572 384573 384574 384575 384576 384578 384345 384346 384347 384348 384349 384351 385203 385204 384221 384222 384223 384224 384225 384226 384228 384229 384230
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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