FDA Device recall Z-0441-2024
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1
- FDA Device
- Class II
- terminated
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1 by Abiomed, citing pump not detected as connected to controller due to software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0441-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-10-10 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abiomed |
| Distribution | AZ, CA, FL, NY, VA |
Product
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Reason
Pump not detected as connected to controller due to software issue.
Identifiers
| code_info | UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2024%22
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