Abiomed recalls
Abiomed appears in 83 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, CA
FDA Device · Class II · 2024-09-11 · Abiomed
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential… - Impella CP Smart Assist Set, Canada
FDA Device · Class II · 2024-09-11 · Abiomed
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential… - Impella 5.5 Set AU
FDA Device · Class II · 2024-09-11 · Abiomed
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential… - Impella 5.5 with SmartAssist Set, US
FDA Device · Class II · 2024-09-11 · Abiomed
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential… - Impella 5.5 with SmartAssist Set, EU
FDA Device · Class II · 2024-09-11 · Abiomed
Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential… - Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
FDA Device · Class I · 2024-07-24 · Abiomed
Reason: Nine (9) Impella CP pumps failed inspection and were inadvertently released. - 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
Reason: Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC. - 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
Reason: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. - 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
Reason: New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device. - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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 mi… - 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
Reason: 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; S… - 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
Reason: Pump not detected as connected to controller due to software issue. - 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
Reason: Pump not detected as connected to controller due to software issue. - Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
FDA Device · Class I · 2023-08-09 · Abiomed
Reason: 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… - Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
FDA Device · Class I · 2023-07-26 · Abiomed
Reason: 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 res… - Impella CP intravascular micro axial blood pump, Product Number 0048-0032
FDA Device · Class I · 2023-07-26 · Abiomed
Reason: 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 res… - Impella 2.5 intravascular micro axial blood pump, Product Number 005042
FDA Device · Class I · 2023-07-26 · Abiomed
Reason: 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 res… - Impella 5.0 intravascular micro axial blood pump, Product Number 005062
FDA Device · Class I · 2023-07-26 · Abiomed
Reason: 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 res… - Impella LD intravascular micro axial blood pump, Product Number 005082
FDA Device · Class I · 2023-07-26 · Abiomed
Reason: 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 res… - Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
FDA Device · Class I · 2023-07-26 · Abiomed
Reason: 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 res… - Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
FDA Device · Class II · 2023-07-19 · Abiomed
Reason: 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 introduce… - 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
Reason: The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. - OXY-1 System, Model Number 001-0500-001
FDA Device · Class I · 2022-02-09 · Abiomed
Reason: 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 hypoxi… - lmpella CP with Smart Assist, Model Number: 0048-0003
FDA Device · Class II · 2019-11-13 · Abiomed
Reason: 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.…