FDA recall record · openFDA
Abiomed, Inc.
56 FDA recalls on record (2023–2026) — 56 device. 54 still ongoing.
22
Class I (most serious)
34
Class II
0
Class III
54
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary 18
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the 10
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcat 6
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. 3
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placem 2
Recalls
Impella RP Flex with SmartAssist. Product Code: 1000323. Class I 2026-01-27 Impella RP with SmartAssist. Product Code: 0046-0035. Class I 2026-01-27 Impella RP. Product Code: 0046-0011. Class I 2026-01-27 Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller Class I 2026-02-16 Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat Class I 2026-02-18 Automated Impella Controller (AIC); Product Code: 0042-0000-US; Class I 2026-04-20 Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Contr Class I 2025-06-23 Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co Class I 2025-08-20 Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Class I 2025-10-01 Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect Class I 2025-09-16 Impella RP Flex with SmartAssist; Product Number: 1000323; Class I 2024-12-12 Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump Class I 2024-05-31 Impella RP with SmartAssist; Product Number: 0046-0035; Class I 2024-12-12 Impella LD intravascular micro axial blood pump, Product Number 005082 Class I 2023-06-14 Impella 5.0 intravascular micro axial blood pump, Product Number 005062 Class I 2023-06-14 Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory s Class I 2023-04-17 Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod Class I 2023-12-27 Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080 Class I 2023-06-14 Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 Class I 2023-06-29 Impella 2.5 intravascular micro axial blood pump, Product Number 005042 Class I 2023-06-14 Impella CP intravascular micro axial blood pump, Product Number 0048-0032 Class I 2023-06-14 Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100 Class I 2023-06-14 Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. Class II 2025-12-04 ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; Class II 2024-08-05 Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; Class II 2024-08-05 Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; Class II 2024-08-05 Pump 381 Pump Set (US); Product Code: 1000080; Class II 2024-08-05 Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; Class II 2024-08-05 Impella CP Smart Assist Set APAC; Product Code: 0048-0047; Class II 2024-08-05 Impella CP Smart Assist Set; Product Code: 1000402; Class II 2024-08-05 Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; Class II 2024-08-05 Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; Class II 2024-08-05 Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; Class II 2024-08-05 Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; Class II 2024-08-05 Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; Class II 2024-08-05 Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; Class II 2024-08-05 Impella CP Smart Assist Set, EU; Product Code: 0048-0014; Class II 2024-08-05 Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; Class II 2024-08-05 Pump 371 14F LT CMR Set; Product Code: 0048-0045; Class II 2024-08-05 Impella 5.5 Set AU; Product Code: 1000361; Class II 2024-08-05 Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; Class II 2024-08-05 Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte Class II 2023-11-07 Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Imp Class II 2023-11-07 Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code Class II 2023-12-27 Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body Class II 2023-11-07 Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Class II 2023-11-07 Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. Class II 2023-10-10 Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp Class II 2023-11-07 Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Class II 2023-11-07 Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca Class II 2023-11-07 Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 Class II 2023-05-26 Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of th Class II 2023-11-07 Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote Class II 2023-12-06 Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Class II 2023-11-07 Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for i Class II 2023-11-07 Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1. Class II 2023-10-10
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.