Recall archive / FDA device enforcement
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1. — FDA record Z-0440-2024
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
- Reason
- Pump not detected as connected to controller due to software issue.
- Classification
- Class II
- Recalling firm
- Abiomed, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Terminated
- Source record identifier
- Z-0440-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AZ, CA, FL, NY & VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 13, 2023
- Recall initiation date
- Oct 10, 2023
- Center classification date
- Dec 1, 2023
- Termination date
- Mar 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.