Z-0441-2024Class II

Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1

Name: Z-0441-2024 Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1
Creator: Abiomed, Inc.
Published: 2023-10-10
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2023-10-10 / Terminated / root cause: software

FDA source

Abiomed, Inc. began a recall of Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1 on 2023-10-10. FDA classified it as Class II and gives the reason as "Pump not detected as connected to controller due to software issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0441-2024
Classification: Class II
Status: Terminated
Initiated: 2023-10-10
Posted: 2023-12-01
Terminated: 2025-03-06
Recalling firm: Abiomed, Inc.
Product: Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Reason for recall: Pump not detected as connected to controller due to software issue.
Root cause tag: software
FDA root cause: Software design
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.
Distribution: US: AZ, CA, FL, NY & VA.
Product codes and lots: UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0441-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0440-2024	Class II	Terminated	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0441-2024	Class II	Terminated	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)