Automated Impella Controller (Abiomed) – Software Connection Issue (2023)
A software issue can prevent proper pump detection, potentially affecting medical device functionality.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Brand
Abiomed, Inc.
Lot Codes / Batch Numbers
UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404.
Products Sold
UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404.
Abiomed, Inc. is recalling Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4. due to Pump not detected as connected to controller due to software issue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Pump not detected as connected to controller due to software issue.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, NY, VA
Page updated: Jan 10, 2026