Z-1175-2024Class II

Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella...

Name: Z-1175-2024 Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella...
Creator: Abiomed, Inc.
Published: 2021-03-01
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2021-03-01 / Terminated / root cause: software

FDA source

Abiomed, Inc. began a recall of Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular) on 2021-03-01. FDA classified it as Class II and gives the reason as "Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC". 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-1175-2024
Classification: Class II
Status: Terminated
Initiated: 2021-03-01
Posted: 2024-02-22
Terminated: 2025-03-06
Recalling firm: Abiomed, Inc.
Product: Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Reason for recall: Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
Root cause tag: software
FDA root cause: Software design
Action: This is a retrospective report for the March 2021 Technical Bulletin, which described a Product Update; specifically the AIC Version 8.5 Software Update. The software update began rollout on March 4, 2021. According to the firm, Version 8.5 of the software contained bug fixes for the issues seen in version 8.4. The technical bulletin was posted to HeartRecovery.com on March 5, 2021.
Quantity in commerce: 4,463 (US)
Distribution: US Nationwide distribution.
Product codes and lots: Product Code 0042-0000-US UDI-DI 00813502010022; Product Code 0042-0010-US UDI-DI 00813502010985; Product Code 0042-0040-US UDI-DI 00813502011401; Software Versions V8.4 and V8.4.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1175-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1175-2024	Class II	Terminated	Voluntary: Firm initiated	2024-02-28	2024-02-22

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)