FDA Device recall Z-2965-2024
Impella 5.5 with SmartAssist S2 Set, US
- FDA Device
- Class II
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class II recall of Impella 5.5 with SmartAssist S2 Set, US by Abiomed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2965-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-05 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abiomed |
| Distribution | US |
Product
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Reason
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.
Identifiers
| code_info | Product Code: 1000100; UDI-DI: 00813502012828; Serial Numbers: 417756 417055 417820 417817 417818 416967 416968 417054…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2965-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.