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Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAs... (Abiomed, Inc.) – device packaged in incorrect outer bo... (2025)

Device packaged in incorrect outer box carton.

Moderate

FDADec 4, 2025Nationwide• Abiomed, Inc.

Impella Controller (Abiomed) – cybersecurity vulnerability (2025)

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Moderate

FDAOct 1, 2025Nationwide• Abiomed, Inc.

Impella Controller (Abiomed) – Purge Pressure Problem (2025)

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Moderate

FDASep 16, 2025Nationwide• Abiomed, Inc.

Impella Controller (Abiomed) – Pump Driver Circuit Issue (2025)

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.

Moderate

FDAAug 20, 2025AZ, AR, CA +14 more• Abiomed, Inc.

Impella Controller (Abiomed) – Pump Detection Problem (2025)

A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

Moderate

FDAJun 23, 2025Nationwide• Abiomed, Inc.

Impella RP with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

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.

Moderate

FDADec 12, 2024Nationwide• Abiomed, Inc.

Impella RP Flex with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

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.

Moderate

FDADec 12, 2024Nationwide• Abiomed, Inc.

Impella CP Smart Assist Set APAC (Abiomed) – Device Interaction Risk (2024)

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.

High