Abiomed recalls
Abiomed appears in 79 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Impella 5.5 with SmartAssist Set, EU
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
FDA Device · Class I · 2024-07-24 · Abiomed - Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (ca…
FDA Device · Class II · 2024-02-28 · Abiomed - Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.…
FDA Device · Class I · 2024-02-21 · Abiomed - Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.…
FDA Device · Class II · 2024-02-21 · Abiomed - Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introducti…
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter i…
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter…
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into…
FDA Device · Class II · 2024-01-17 · Abiomed - 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…
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter i…
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the…
FDA Device · Class II · 2024-01-17 · Abiomed - Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021
FDA Device · Class II · 2024-01-17 · Abiomed - Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data
FDA Device · Class II · 2024-01-10 · Abiomed - Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1
FDA Device · Class II · 2023-12-13 · Abiomed - Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1
FDA Device · Class II · 2023-12-13 · Abiomed - Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
FDA Device · Class I · 2023-08-09 · Abiomed - Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
FDA Device · Class I · 2023-07-26 · Abiomed - Impella CP intravascular micro axial blood pump, Product Number 0048-0032
FDA Device · Class I · 2023-07-26 · Abiomed - Impella 2.5 intravascular micro axial blood pump, Product Number 005042
FDA Device · Class I · 2023-07-26 · Abiomed - Impella 5.0 intravascular micro axial blood pump, Product Number 005062
FDA Device · Class I · 2023-07-26 · Abiomed - Impella LD intravascular micro axial blood pump, Product Number 005082
FDA Device · Class I · 2023-07-26 · Abiomed - Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
FDA Device · Class I · 2023-07-26 · Abiomed - Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
FDA Device · Class II · 2023-07-19 · Abiomed - Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numb…
FDA Device · Class I · 2023-05-24 · Abiomed - OXY-1 System, Model Number 001-0500-001
FDA Device · Class I · 2022-02-09 · Abiomed - lmpella CP with Smart Assist, Model Number: 0048-0003
FDA Device · Class II · 2019-11-13 · Abiomed