Class II — Abiomed, Inc.
| Recalling firm | ABIOMED, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Pump not detected as connected to controller due to software issue. |
| Product | Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. |
| Distribution | US: AZ, CA, FL, NY & VA. |
| Initiated | 2023-10-10 |
| Classified | 2023-12-01 |
| Terminated | 2025-03-06 |
| Recall number | Z-0441-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abiomed, Inc. (Z-0441-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93406/
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