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Terminated

Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

FDA Recall Z-0440-2024 · Posted 2023-12-01

Recalling FirmAbiomed, Inc.
Recall StatusTerminated
Product CodeOZD
Date Initiated2023-10-10
Date Terminated2025-03-06

Reason for Recall

Pump not detected as connected to controller due to software issue.

Firm Action

An Urgent Medical Device Correction was issued vail mail October 24. 2023. Customers are advised to examine inventory for product running AIC software version: V8.4 or V8.4.1. Do not to use the product unless software is updated. Contact [email protected] to schedule the software update and return the business reply form. Forward this information to relevant personnel and any facility product may have been transferred to.

Root Cause

Software design

Distribution Pattern

US: AZ, CA, FL, NY & VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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