Abiomed, Inc.: Device Recall

Recall #Z-2319-2024 · 05/31/2024

Class I: Dangerous

Recall Details

Recall Number: Z-2319-2024
Classification: Class I
Product Type: Device
Recalling Firm: Abiomed, Inc.
Status: Ongoing
Date Initiated: 05/31/2024
Location: Danvers, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9 units

Reason for Recall

Nine (9) Impella CP pumps failed inspection and were inadvertently released.

Product Description

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

Distribution Pattern

Domestic only: FL, MA, OH TX.

Other Recalls by Abiomed, Inc.

Class II: Risk 12/04/2025

Device packaged in incorrect outer box carton.
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

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.