Countries where the notices were issued: United States (25).
Name as written in the notices: Abiomed, Inc.. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.
| Date | Authority | Product | Hazard (as classified) |
|---|
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Cod | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Tap | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pum | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessori | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Tap | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-300 | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessori | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006- | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-30 | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. h | — |
| 2026-06-11 | US FDA — Medical Devices | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer P | — |
| 2026-04-20 | US FDA — Medical Devices | Automated Impella Controller (AIC); Product Code: 0042-0000-US; | — |
| 2025-08-20 | US FDA — Medical Devices | Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co | — |
| 2024-12-12 | US FDA — Medical Devices | Impella RP Flex with SmartAssist; Product Number: 1000323; | — |
| 2024-08-05 | US FDA — Medical Devices | ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; | — |
| 2024-08-05 | US FDA — Medical Devices | Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; | — |
| 2024-08-05 | US FDA — Medical Devices | Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; | — |
| 2024-08-05 | US FDA — Medical Devices | Pump 381 Pump Set (US); Product Code: 1000080; | — |
| 2024-08-05 | US FDA — Medical Devices | Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; | — |
| 2024-08-05 | US FDA — Medical Devices | Impella CP Smart Assist Set APAC; Product Code: 0048-0047; | — |
| 2024-08-05 | US FDA — Medical Devices | Impella CP Smart Assist Set; Product Code: 1000402; | — |
| 2024-08-05 | US FDA — Medical Devices | Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; | — |
| 2024-08-05 | US FDA — Medical Devices | Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; | — |