Abiomed, Inc.: Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;

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: 11,576 units Lot/code info: Product Code: 1000100; UDI-DI: 00813502012828; Serial Numbers: 417756 417055 417820 417817 417818 416967 416968 417054 417056 417057 417058 417819 417821 417042 416991 417043 417024 417025 417026 417027 417028 417234 417235 417236 416989 416990 416992 416993 417040 417041 416864 416865 416866 416867 416962 416959 416887 416888 416963 417237 417238 416897 416869 416872 416873 416886 416961 416960 417833 416870 416871 416855 416854 416858 417244 417246 417245 416884 416885 417061 417062 417063 417815 417269 417270 417271 417272 417785 417786 417768 417769 417770 417771 417239 417240 417242 417243 417060 417247 417808 417809 417811 417814 417273 417782 417783 417784 417937 417938 417939 417940 417941 417498 417264 417265 417266 417267 417268 417955 417956 417494 417495 417465 417466 417467 418015 418018 418019 417816 417952 417953 417954 417497 417464 418016 418017 418732 418733 418715 418716 418717 418718 417496 418700 418701 418702 416859 416860 416861 416862 416863 418729 418730 417249 417250 417251 417252 419011 418699 418703 418175 418176 418177 418731 420411 418744 418745 418746 418253 420973 420985 420986 420987 420988 420989 418170 418172 418020 418021 420410 418747 418748 418249 418250 418251 418252 418022 418024 420974 419093 419094 419095 419096 419097 418256 418257 420441 420442 420412 420413 418053 418054 420445 420446 420447 420448 418254 418255 417604 417605 417606 417607 417608 417659 418154 418157 417660 417661 417662 417663 420414 418050 418051 418052 420535 42

UPC codes

00813502012828

Source

Official record: FDA (Device enforcement) ↗

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