Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
- Company
- Abiomed, Inc.
- Recall Initiated
- October 10, 2023
- Posted
- December 1, 2023
- Terminated
- March 6, 2025
- Recall Number
- Z-0440-2024
- Firm Location
- Danvers, MA
Reason for Recall
Pump not detected as connected to controller due to software issue.
Distribution
US: AZ, CA, FL, NY & VA.
Lot / Code Info
UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404.
Root Cause
Software design
Action Taken
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 adminsfs@abiomed.com 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.
More recalls by Abiomed, Inc.
Impella RP. Product Code: 0046-0011.
Feb 27, 2026