Abiomed, Inc.
32 recalls on record · Latest: Oct 29, 2025
FDA Devices Critical Oct 29, 2025
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 100043…
FDA Devices Critical Oct 15, 2025
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Co…
FDA Devices Critical Oct 1, 2025
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Produ…
FDA Devices Critical Aug 6, 2025
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product …
FDA Devices Critical Jan 22, 2025
Impella RP Flex with SmartAssist; Product Number: 1000323;
FDA Devices Moderate Sep 11, 2024
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
FDA Devices Moderate Sep 11, 2024
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
FDA Devices Moderate Sep 11, 2024
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
FDA Devices Moderate Sep 11, 2024
Pump 381 Pump Set (US); Product Code: 1000080;
FDA Devices Moderate Sep 11, 2024
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
FDA Devices Moderate Sep 11, 2024
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
FDA Devices Moderate Sep 11, 2024
Impella CP Smart Assist Set; Product Code: 1000402;
FDA Devices Moderate Sep 11, 2024
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
FDA Devices Moderate Sep 11, 2024
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
FDA Devices Moderate Sep 11, 2024
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
FDA Devices Moderate Sep 11, 2024
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
FDA Devices Critical Jul 24, 2024
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
FDA Devices Moderate Feb 28, 2024
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascu…
FDA Devices Moderate Feb 21, 2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Pro…
FDA Devices Critical Feb 21, 2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) …
FDA Devices Moderate Jan 17, 2024
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the …
FDA Devices Moderate Jan 17, 2024
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. …
FDA Devices Moderate Jan 17, 2024
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 I…
FDA Devices Moderate Jan 17, 2024
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the bo…
FDA Devices Moderate Jan 17, 2024
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. …
FDA Devices Moderate Jan 17, 2024
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the bo…
FDA Devices Moderate Jan 17, 2024
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part N…
FDA Devices Moderate Dec 13, 2023
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
FDA Devices Critical Jul 26, 2023
Impella LD intravascular micro axial blood pump, Product Number 005082
FDA Devices Critical Jul 26, 2023
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
FDA Devices Critical Jul 26, 2023
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
FDA Devices Critical May 24, 2023