Abiomed, Inc.: Device Recall

Recall #Z-1030-2026 · 12/04/2025

Class II: Risk

Recall Details

Recall Number: Z-1030-2026
Classification: Class II
Product Type: Device
Recalling Firm: Abiomed, Inc.
Status: Ongoing
Date Initiated: 12/04/2025
Location: Danvers, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 units

Reason for Recall

Device packaged in incorrect outer box carton.

Product Description

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Distribution Pattern

International distribution to the country of Australia.

Other Recalls by Abiomed, Inc.

Class I: Dangerous 10/01/2025

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Class I: Dangerous 09/16/2025

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Class I: Dangerous 08/20/2025

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.
Class I: Dangerous 06/23/2025

A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Class I: Dangerous 12/12/2024

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.

View all recalls by Abiomed, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.