| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. hear | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer P | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introd | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Pro | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr I | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. hear | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, S | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product C | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052 | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introd | Abiomed, Inc. | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro | Abiomed, Inc. | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. | Abiomed, Inc. | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. | Abiomed, Inc. | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro | Abiomed, Inc. | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. | Abiomed, Inc. | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the foll | Abiomed, Inc. | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod | Abiomed, Inc. | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US; | Abiomed, Inc. | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in | Abiomed, Inc. | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1 | Abiomed, Inc. | Class I | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Impella RP with SmartAssist. Product Code: 0046-0035. | Abiomed, Inc. | Class I | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Impella RP. Product Code: 0046-0011. | Abiomed, Inc. | Class I | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Impella RP Flex with SmartAssist. Product Code: 1000323. | Abiomed, Inc. | Class I | N/A |