Brand

Abiomed, Inc. Recalls

35 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Abiomed, Inc..

35Total Recalls
16Critical
319,794Units Affected
Feb 18, 2026Most Recent
All Recalls

Every Abiomed, Inc. Recall

Sorted by most recent. Click any recall for full details.

35 recalls
CriticalFDA
Abiomed, Inc.
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and correspo...
Medical Devices·33,107 affected·Feb 18, 2026
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; P...
Medical Devices·62 affected·Feb 16, 2026
CriticalFDA
Abiomed, Inc.
Impella RP Flex with SmartAssist. Product Code: 1000323.
Medical Devices·4,496 affected·Jan 27, 2026
CriticalFDA
Abiomed, Inc.
Impella RP with SmartAssist. Product Code: 0046-0035.
Medical Devices·291 affected·Jan 27, 2026
CriticalFDA
Abiomed, Inc.
Impella RP. Product Code: 0046-0011.
Medical Devices·179 affected·Jan 27, 2026
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1...
Cardiac Devices·10,153 affected·Oct 1, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product ...
Medical Devices·9,177 affected·Sep 16, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Package...
Cardiac Devices·71 affected·Aug 20, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, ...
Cardiac Devices·11,031 affected·Jun 23, 2025
CriticalFDA
Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Medical Devices·2,364 affected·Dec 12, 2024
High RiskFDA
Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Medical Devices·8 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Medical Devices·9 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Medical Devices·788 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Pump 381 Pump Set (US); Product Code: 1000080;
Medical Devices·11,236 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Medical Devices·1,889 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Medical Devices·705 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402;
Medical Devices·39 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Medical Devices·286 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Medical Devices·11,576 affected·Aug 5, 2024
CriticalFDA
Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Cardiac Devices·9 affected·May 31, 2024
High RiskFDA
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella...
Surgical Devices·92,515 affected·Dec 27, 2023
CriticalFDA
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impell...
Surgical Devices·91,914 affected·Dec 27, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduc...
Surgical Devices·2,551 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
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 int...
Surgical Devices·1 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0...
Surgical Devices·717 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter...
Surgical Devices·0 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter int...
Surgical Devices·3 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter...
Surgical Devices·1,784 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the b...
Surgical Devices·4 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Medical Devices·0 affected·Oct 10, 2023
CriticalFDA
Abiomed, Inc.
Impella LD intravascular micro axial blood pump, Product Number 005082
Medical Devices·9,252 affected·Jun 14, 2023
CriticalFDA
Abiomed, Inc.
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Medical Devices·9,252 affected·Jun 14, 2023
CriticalFDA
Abiomed, Inc.
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Medical Devices·9,252 affected·Jun 14, 2023
CriticalFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Nu...
Surgical Devices·610 affected·Apr 17, 2023
High RiskFDA
Abiomed, Inc.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems ...
Medical Devices·4,463 affected·Mar 1, 2021