Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Pa

FDA device recall Z-1591-2026 · posted 2026-03-27 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Action taken

Abiomed notified international consignees on about 02/16/2026 via emailed CRITICAL PRODUCT CORRECTION letter. Consignees were instructed to cease use of the Automated Impella Controller (AIC) with an Impella 5.5 S1 (product code 0550-0007) unless AIC software is updated to v10.1 or above, identify current software in the lower left corner of the initial AIC display screen, contact your local Abiomed representative to schedule your software update, review and complete the customer response form provided and post this notification in a visible area for awareness. Consignees were also instructed to forward this notification to anyone within the facility that should be aware and forward the notification to consignees if further distributed.

Root cause

Software design

Status

Open, Classified

Product code

OZD

Quantity affected

62 units

Distribution

International distribution in the country of Australia, Canada, France, Germany, Kuwait.

Date initiated

2026-02-16

Date posted

2026-03-27

Location

Danvers, MA