Abiomed, Inc.
Danvers, MA
This page shows every FDA and USDA recall linked to Abiomed, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
63
Total Recalls
2003
First Recall
2026
Most Recent
Impella RP Flex with SmartAssist. Product Code: 1000323.
Feb 27, 2026
· Device
Open, Classified
Impella RP. Product Code: 0046-0011.
Feb 27, 2026
· Device
Open, Classified
Impella RP with SmartAssist. Product Code: 0046-0035.
Feb 27, 2026
· Device
Open, Classified
Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
Jan 8, 2026
· Device
Open, Classified
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes:
1. AIC w/Impell...
Oct 17, 2025
· Device
Open, Classified
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corr...
Oct 9, 2025
· Device
Open, Classified
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump.
1....
Sep 19, 2025
· Device
Open, Classified
Automated Impella Controller (AIC), used in left heart support blood pump, including the following:
1. Impel...
Jul 26, 2025
· Device
Open, Classified
Impella RP with SmartAssist; Product Number: 0046-0035;
Jan 15, 2025
· Device
Open, Classified
Impella RP Flex with SmartAssist; Product Number: 1000323;
Jan 15, 2025
· Device
Open, Classified
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
Sep 4, 2024
· Device
Open, Classified
Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
Sep 4, 2024
· Device
Open, Classified
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
Sep 4, 2024
· Device
Open, Classified
Pump 371 14F LT CMR Set; Product Code: 0048-0045;
Sep 4, 2024
· Device
Open, Classified
Impella 5.5 Set AU; Product Code: 1000361;
Sep 4, 2024
· Device
Open, Classified
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Sep 4, 2024
· Device
Open, Classified
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
Sep 4, 2024
· Device
Open, Classified
Impella CP Smart Assist Set; Product Code: 1000402;
Sep 4, 2024
· Device
Open, Classified
Pump 381 Pump Set (US); Product Code: 1000080;
Sep 4, 2024
· Device
Open, Classified
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Sep 4, 2024
· Device
Open, Classified
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Sep 4, 2024
· Device
Open, Classified
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Sep 4, 2024
· Device
Open, Classified
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Sep 4, 2024
· Device
Open, Classified
Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
Sep 4, 2024
· Device
Open, Classified
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Sep 4, 2024
· Device
Open, Classified
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Sep 4, 2024
· Device
Open, Classified
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Sep 4, 2024
· Device
Open, Classified
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Sep 4, 2024
· Device
Open, Classified
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Jul 17, 2024
· Device
Open, Classified
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella V...
Feb 22, 2024
· Device
Terminated
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.
(1) Pr...
Feb 12, 2024
· Device
Open, Classified
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.
(1) P...
Feb 9, 2024
· Device
Open, Classified
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction...
Jan 5, 2024
· Device
Open, Classified
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter int...
Jan 5, 2024
· Device
Open, Classified
Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduc...
Jan 5, 2024
· Device
Open, Classified
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction...
Jan 5, 2024
· Device
Open, Classified
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the...
Jan 5, 2024
· Device
Open, Classified
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduct...
Jan 5, 2024
· Device
Open, Classified
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s...
Jan 5, 2024
· Device
Open, Classified
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-000...
Jan 5, 2024
· Device
Open, Classified
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are inte...
Jan 5, 2024
· Device
Open, Classified
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduct...
Jan 5, 2024
· Device
Open, Classified
Impella Connect, software portal for online device management that allows clinicians and Impella support staff...
Jan 4, 2024
· Device
Open, Classified
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Dec 1, 2023
· Device
Terminated
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Dec 1, 2023
· Device
Terminated
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Aug 3, 2023
· Device
Open, Classified
Impella LD intravascular micro axial blood pump, Product Number 005082
Jul 14, 2023
· Device
Open, Classified
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Jul 14, 2023
· Device
Open, Classified
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Jul 14, 2023
· Device
Open, Classified
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 100008...
Jul 14, 2023
· Device
Open, Classified