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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 50 of 50 Results
Recall Date from: 12/22/2022 Firm: abiomed
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Product Description
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Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AI... 1 10/17/2025 Abiomed, Inc.
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following... 1 10/09/2025 Abiomed, Inc.
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist p... 1 09/19/2025 Abiomed, Inc.
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: ... 1 07/26/2025 Abiomed, Inc.
Impella RP with SmartAssist; Product Number: 0046-0035; 1 01/15/2025 Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323; 1 01/15/2025 Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; 2 09/04/2024 Abiomed, Inc.
Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; 2 09/04/2024 Abiomed, Inc.
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; 2 09/04/2024 Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; 2 09/04/2024 Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047; 2 09/04/2024 Abiomed, Inc.
Pump 371 14F LT CMR Set; Product Code: 0048-0045; 2 09/04/2024 Abiomed, Inc.
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; 2 09/04/2024 Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; 2 09/04/2024 Abiomed, Inc.
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; 2 09/04/2024 Abiomed, Inc.
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; 2 09/04/2024 Abiomed, Inc.
Impella CP Smart Assist Set, EU; Product Code: 0048-0014; 2 09/04/2024 Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; 2 09/04/2024 Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; 2 09/04/2024 Abiomed, Inc.
Impella 5.5 Set AU; Product Code: 1000361; 2 09/04/2024 Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402; 2 09/04/2024 Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; 2 09/04/2024 Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; 2 09/04/2024 Abiomed, Inc.
Pump 381 Pump Set (US); Product Code: 1000080; 2 09/04/2024 Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump 1 07/17/2024 Abiomed, Inc.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with... 2 02/22/2024 Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory syste... 2 02/12/2024 Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory syste... 1 02/09/2024 Abiomed, Inc.
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for int... 2 01/05/2024 Abiomed, Inc.
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Ca... 2 01/05/2024 Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for... 2 01/05/2024 Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for... 2 01/05/2024 Abiomed, Inc.
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035... 2 01/05/2024 Abiomed, Inc.
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for int... 2 01/05/2024 Abiomed, Inc.
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introducti... 2 01/05/2024 Abiomed, Inc.
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s... 2 01/05/2024 Abiomed, Inc.
Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended fo... 2 01/05/2024 Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-In... 2 01/05/2024 Abiomed, Inc.
Impella Connect, software portal for online device management that allows clinicians and Impella sup... 2 01/04/2024 Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.... 2 12/01/2023 Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.... 2 12/01/2023 Abiomed, Inc.
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 1 08/03/2023 Abiomed, Inc.
Impella CP intravascular micro axial blood pump, Product Number 0048-0032 1 07/14/2023 Abiomed, Inc.
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-00... 1 07/14/2023 Abiomed, Inc.
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 100... 1 07/14/2023 Abiomed, Inc.
Impella 2.5 intravascular micro axial blood pump, Product Number 005042 1 07/14/2023 Abiomed, Inc.
Impella LD intravascular micro axial blood pump, Product Number 005082 1 07/14/2023 Abiomed, Inc.
Impella 5.0 intravascular micro axial blood pump, Product Number 005062 1 07/14/2023 Abiomed, Inc.
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 2 07/11/2023 Abiomed, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a pat... 1 05/18/2023 Abiomed, Inc.
 
 
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