Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding

FDA device recall Z-0069-2026 · posted 2025-10-09 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Action taken

Abiomed notified consignees via UPS delivery on about 10/01/2025. Consignees were informed of the potential cybersecurity vulnerabilities related to network and physical access. Next steps included that product was not being removed, to maintain the affected device in a secure environment with restricted access, and an Abiomed field representative will contact consignees to arrange disabling the AIC's network capabilities. Consignees were instructed to review the notice and forward it to applicable personnel or customers if further distributed, report any suspicions of a cybersecurity event, and complete and return the response form. A follow up notification was sent to non-responding consignees on about 11/12/2025. The letter informed consignees that they were being contacted because they have not returned the response to the first notification. If a completed Business Reply Form is not received before a third notification letter (approximately 30 days), Abiomed will proactively disable remote viewing capabilities on Impella Connect.

Root cause

Software design

Status

Open, Classified

Product code

OZD

Quantity affected

10,153 units

Distribution

Nationwide distribution. International distribution to United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Colombia, Czechia, Germany, Denmark, Spain, Fi

Date initiated

2025-10-01

Date posted

2025-10-09

Location

Danvers, MA