| ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr recall (Z-2681-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 recall (Z-2682-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing K recall (Z-2683-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introduce recall (Z-2684-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 1 recall (Z-2685-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 1 recall (Z-2686-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Intr recall (Z-2687-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing In recall (Z-2688-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3 recall (Z-2689-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer recall (Z-2690-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3 recall (Z-2691-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product recall (Z-2692-2026) | Abiomed, Inc. | 2026-07-10 |
| ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing I recall (Z-2693-2026) | Abiomed, Inc. | 2026-07-10 |
| Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: recall (Z-2599-2026) | Abiomed, Inc. | 2026-06-25 |
| Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: recall (Z-2600-2026) | Abiomed, Inc. | 2026-06-25 |
| Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall (Z-2601-2026) | Abiomed, Inc. | 2026-06-25 |
| Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall (Z-2602-2026) | Abiomed, Inc. | 2026-06-25 |
| Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. recall (Z-2457-2026) | Abiomed, Inc. | 2026-06-18 |
| Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as recall (Z-2360-2026) | Abiomed, Inc. | 2026-06-12 |
| Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall (Z-2238-2026) | Abiomed, Inc. | 2026-05-28 |
| Automated Impella Controller (AIC); Product Code: 0042-0000-US; recall (Z-2211-2026) | Abiomed, Inc. | 2026-05-22 |
| Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distr recall (Z-1589-2026) | Abiomed, Inc. | 2026-03-31 |
| Automated Impella Controller (AIC), labeled as the following with corresponding Product Co recall (Z-1591-2026) | Abiomed, Inc. | 2026-03-27 |
| Impella RP with SmartAssist. Product Code: 0046-0035. recall (Z-1469-2026) | Abiomed, Inc. | 2026-02-27 |
| Impella RP Flex with SmartAssist. Product Code: 1000323. recall (Z-1470-2026) | Abiomed, Inc. | 2026-02-27 |
| Impella RP. Product Code: 0046-0011. recall (Z-1471-2026) | Abiomed, Inc. | 2026-02-27 |
| Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU. recall (Z-1030-2026) | Abiomed, Inc. | 2026-01-08 |
| Automated Impella Controller (AIC) labeled as the following with corresponding Product Cod recall (Z-0136-2026) | Abiomed, Inc. | 2025-10-17 |
| Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the recall (Z-0069-2026) | Abiomed, Inc. | 2025-10-09 |
| Automated Impella Controller (AIC) with the below brands and product codes. Used with hear recall (Z-2568-2025) | Abiomed, Inc. | 2025-09-19 |
| Automated Impella Controller (AIC), used in left heart support blood pump, including the f recall (Z-2164-2025) | Abiomed, Inc. | 2025-07-26 |
| Impella RP with SmartAssist; Product Number: 0046-0035; recall (Z-0829-2025) | Abiomed, Inc. | 2025-01-15 |
| Impella RP Flex with SmartAssist; Product Number: 1000323; recall (Z-0830-2025) | Abiomed, Inc. | 2025-01-15 |
| Impella CP Smart Assist Set, EU; Product Code: 0048-0014; recall (Z-2954-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; recall (Z-2955-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; recall (Z-2956-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; recall (Z-2957-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; recall (Z-2958-2024) | Abiomed, Inc. | 2024-09-04 |
| Pump 371 14F LT CMR Set; Product Code: 0048-0045; recall (Z-2959-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella CP Smart Assist Set APAC; Product Code: 0048-0047; recall (Z-2960-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; recall (Z-2961-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; recall (Z-2962-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; recall (Z-2963-2024) | Abiomed, Inc. | 2024-09-04 |
| Pump 381 Pump Set (US); Product Code: 1000080; recall (Z-2964-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; recall (Z-2965-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; recall (Z-2966-2024) | Abiomed, Inc. | 2024-09-04 |
| ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; recall (Z-2967-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella 5.5 Set AU; Product Code: 1000361; recall (Z-2968-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella CP Smart Assist Set; Product Code: 1000402; recall (Z-2969-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; recall (Z-2970-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; recall (Z-2971-2024) | Abiomed, Inc. | 2024-09-04 |
| Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support bloo recall (Z-2319-2024) | Abiomed, Inc. | 2024-07-17 |
| Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. recall (Z-1175-2024) | Abiomed, Inc. | 2024-02-22 |
| Impella catheters - Intravascular micro axial blood pumps that support a patient's circula recall (Z-1074-2024) | Abiomed, Inc. | 2024-02-12 |
| Impella catheters - Intravascular micro axial blood pumps that support a patient's circula recall (Z-0980-2024) | Abiomed, Inc. | 2024-02-09 |
| Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the recall (Z-0646-2024) | Abiomed, Inc. | 2024-01-05 |
| Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for recall (Z-0647-2024) | Abiomed, Inc. | 2024-01-05 |
| Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intend recall (Z-0648-2024) | Abiomed, Inc. | 2024-01-05 |
| Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, recall (Z-0649-2024) | Abiomed, Inc. | 2024-01-05 |
| Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are in recall (Z-0650-2024) | Abiomed, Inc. | 2024-01-05 |
| Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are in recall (Z-0651-2024) | Abiomed, Inc. | 2024-01-05 |
| Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1 recall (Z-0652-2024) | Abiomed, Inc. | 2024-01-05 |
| Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intend recall (Z-0653-2024) | Abiomed, Inc. | 2024-01-05 |
| Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-In recall (Z-0654-2024) | Abiomed, Inc. | 2024-01-05 |
| Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are i recall (Z-0655-2024) | Abiomed, Inc. | 2024-01-05 |
| Impella Connect, software portal for online device management that allows clinicians and I recall (Z-0636-2024) | Abiomed, Inc. | 2024-01-04 |
| Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 recall (Z-0440-2024) | Abiomed, Inc. | 2023-12-01 |
| Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 recall (Z-0441-2024) | Abiomed, Inc. | 2023-12-01 |
| Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 100032 recall (Z-2281-2023) | Abiomed, Inc. | 2023-08-03 |
| Impella 2.5 intravascular micro axial blood pump, Product Number 005042 recall (Z-2111-2023) | Abiomed, Inc. | 2023-07-14 |
| Impella 5.0 intravascular micro axial blood pump, Product Number 005062 recall (Z-2112-2023) | Abiomed, Inc. | 2023-07-14 |
| Impella LD intravascular micro axial blood pump, Product Number 005082 recall (Z-2113-2023) | Abiomed, Inc. | 2023-07-14 |
| Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-00 recall (Z-2114-2023) | Abiomed, Inc. | 2023-07-14 |
| Impella CP intravascular micro axial blood pump, Product Number 0048-0032 recall (Z-2115-2023) | Abiomed, Inc. | 2023-07-14 |
| Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-002 recall (Z-2116-2023) | Abiomed, Inc. | 2023-07-14 |
| Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 recall (Z-2128-2023) | Abiomed, Inc. | 2023-07-11 |
| Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supp recall (Z-1590-2023) | Abiomed, Inc. | 2023-05-18 |
| OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System recall (Z-0550-2022) | Abiomed, Inc. | 2022-02-03 |
| Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is in recall (Z-2382-2010) | Abiomed, Inc. | 2010-09-07 |
| Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abio recall (Z-0824-2010) | Abiomed, Inc. | 2010-03-04 |
| iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a recall (Z-1931-2009) | Abiomed, Inc. | 2009-09-16 |
| Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical recall (Z-1914-2009) | Abiomed, Inc. | 2009-09-01 |
| Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD T recall (Z-2304-2008) | Abiomed, Inc. | 2008-09-20 |
| AB5000 Console Circulatory Support System Catalog Number: 0015-0000 recall (Z-0574-2007) | Abiomed, Inc. | 2007-03-07 |
| BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000 recall (Z-1222-03) | Abiomed, Inc. | 2003-09-11 |