Z-0441-2024 Class II Terminated
FDA device recall Z-0441-2024 was initiated by Abiomed, Inc. on October 10, 2023 and is designated Class II. Reason for recall: Pump not detected as connected to controller due to software issue. The recall status is terminated (terminated March 6, 2025).
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- October 10, 2023
- Termination Date
- March 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Reason for Recall
Pump not detected as connected to controller due to software issue.
Distribution Pattern
US: AZ, CA, FL, NY & VA.
Code Information
UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617.