Abiomed, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0440-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

Product Classification:

Class II

Date Initiated: October 10, 2023

Date Posted: December 13, 2023

Recall Number: Z-0440-2024

Event ID: 93406

Reason for Recall:

Pump not detected as connected to controller due to software issue.

Status: Terminated

Product Quantity:

Code Information:

UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404.

Distribution Pattern:

US: AZ, CA, FL, NY & VA.

Voluntary or Mandated:

Voluntary: Firm initiated