Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with correspond

FDA device recall Z-2360-2026 · posted 2026-06-12 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Action taken

Abiomed notified consignees on about 05/14/2026 via letter titled "URGENT MEDICAL DEVICE RECALL (CORRECTION)." Consignees were made aware of the issue and potential risk and were informed that devices were not being removed, and hospital inventory can continue to be used. Specific, outlined scenarios were explained and that if they were to occur, that a console exchange is unnecessary as the phenomenon will recur on the exchange device. Abiomed is actively working on a software update to the AIC to address this issue. Consignees were instructed to complete and return the provided business reply form, forward the notice to anyone in each facility that needs to be informed, post copy of the notice in a visible area for awareness, and if any affected products have been forwarded to another facility, contact that facility and provide them with the notice.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OZD

Quantity affected

10,297 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, I

Date initiated

2026-05-14

Date posted

2026-06-12

Location

Danvers, MA