Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controlle

FDA device recall Z-2164-2025 · posted 2025-07-26 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

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

Action taken

Initially Abiomed posted their recall notification on their website, HeartRecover.com on 06/23/2025. Consignees were also notified on 06/25/2025 via letter. Consignees were advised that devices were not being removed. They were advised to have a back-up Automated Impella Controller (AIC) available in the event of a device failure and were provided work around instruction for console-to-console transfer and case starts. Additionally, consignees were instructed to forward the notification to all pertinent personnel and customers if further distributed and complete and return the business response form provided.

Root cause

Device Design

Status

Open, Classified

Product code

OZD

Quantity affected

11,031 units

Distribution

Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel,

Date initiated

2025-06-23

Date posted

2025-07-26

Location

Danvers, MA