Abiomed Recalls
56 recalls on record in the United States
Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Abiomed, Inc. recalls Impella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Abiomed, Inc. recalls Impella RP. Product Code: 0046-0011.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssi
Device packaged in incorrect outer box carton.
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Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
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Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart supp
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
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Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below brands and
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
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Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart suppo
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
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Abiomed, Inc. recalls Impella RP Flex with SmartAssist; Product Number: 1000323;
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.
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Abiomed, Inc. recalls Impella RP with SmartAssist; Product Number: 0046-0035;
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.
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Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 100030
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.
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Abiomed, Inc. recalls Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-
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.
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Abiomed, Inc. recalls Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
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.
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Abiomed, Inc. recalls Pump 381 Pump Set (US); Product Code: 1000080;
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.
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Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-000
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.
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Abiomed, Inc. recalls Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
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.
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Abiomed, Inc. recalls Impella CP Smart Assist Set; Product Code: 1000402;
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.
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Abiomed, Inc. recalls Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
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.
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Abiomed, Inc. recalls Impella 5.5 with SmartAssist S2 Set, US; Product Code: 10001
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.
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Abiomed, Inc. recalls Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
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.
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Abiomed, Inc. recalls Impella CP Smart Assist Set, Canada; Product Code: 0048-0044
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.
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Abiomed, Inc. recalls Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 10004
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.
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Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-000
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.
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Abiomed, Inc. recalls Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
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.
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Abiomed, Inc. recalls Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
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.
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Abiomed, Inc. recalls Pump 371 14F LT CMR Set; Product Code: 0048-0045;
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.
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Abiomed, Inc. recalls Impella 5.5 Set AU; Product Code: 1000361;
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.
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Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, US; Product Code: 0550-000
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.
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Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
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Abiomed, Inc. recalls Automated Impella Controller (AIC), Product No. 0042-0000-US
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.
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Showing 30 of 56 recalls. See all →