FDA Enforcement
Class II
Terminated
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Recall: Z-0440-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0440-2024
- Event ID
- 93406
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abiomed, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 13, 2023
- Initiation Date
- October 10, 2023
- Classification Date
- December 1, 2023
- Termination Date
- March 6, 2025
- Address
- 24 Cherry Hill Dr, Danvers, MA, 01923-2575, United States
Description
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.
Code Info
UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404.
Distribution
US: AZ, CA, FL, NY & VA.