Abiomed Recalls
79 recalls on record · November 13, 2019 to July 22, 2026 · Medical Devices
Recalls by year
19
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 10, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote
Hazard: The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
December 13, 2023Medical DevicesFDA
Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Hazard: Pump not detected as connected to controller due to software issue.
December 13, 2023Medical DevicesFDA
Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Hazard: Pump not detected as connected to controller due to software issue.
August 9, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Hazard: A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella LD intravascular micro axial blood pump, Product Number 005082
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 19, 2023Medical DevicesFDA
Abiomed, Inc. recalls Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Hazard: There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
May 24, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory s
Hazard: The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
February 9, 2022Medical DevicesFDA
Abiomed, Inc. recalls OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pum
Hazard: The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia.
November 13, 2019Medical DevicesFDA
Abiomed, Inc. recalls lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock
Hazard: This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.