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.
August 6, 2025Medical DevicesFDA
Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Contr
Hazard: A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
January 22, 2025Medical DevicesFDA
Abiomed, Inc. recalls Impella RP Flex with SmartAssist; Product Number: 1000323;
Hazard: Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
January 22, 2025Medical DevicesFDA
Abiomed, Inc. recalls Impella RP with SmartAssist; Product Number: 0046-0035;
Hazard: Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP Smart Assist Set; Product Code: 1000402;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 Set AU; Product Code: 1000361;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Pump 381 Pump Set (US); Product Code: 1000080;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Pump 371 14F LT CMR Set; Product Code: 0048-0045;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
September 11, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Hazard: 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 interaction, so Abiomed will update the IFU to include information on this potential device interaction.
July 24, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Hazard: Nine (9) Impella CP pumps failed inspection and were inadvertently released.
February 28, 2024Medical DevicesFDA
Abiomed, Inc. recalls Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular
Hazard: 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.
February 21, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code
Hazard: 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.
February 21, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod
Hazard: 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.
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of th
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 KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for i
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 Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-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 Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte
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 Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-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