Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Contr

FDA device recall Z-2238-2026 · posted 2026-05-28 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.

Action taken

No customer notifications were sent. The retrospectively reported recall does not currently affect any Automated Impella Controllers (AICs) in the field pending the correction. The hardware update was implemented to AICs in the field through servicing to address potential safety concerns.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OZD

Quantity affected

625 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom

Date initiated

2011-01-17

Date posted

2026-05-28

Location

Danvers, MA