Abiomed, Inc.: Impella CP Smart Assist Set APAC; Product Code: 0048-0047;

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.

Details from the source

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. 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., Unite Quantity: 705 units Lot/code info: 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 39

UPC codes

00813502011944

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.