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

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: 323 units Lot/code info: 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

UPC codes

00813502012200

Source

Official record: FDA (Device enforcement) ↗

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