FDA Enforcement
Class II
Terminated
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Recall: Z-1175-2024
·
Reported February 28, 2024
Enforcement
- Recall Number
- Z-1175-2024
- Event ID
- 93876
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abiomed, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 28, 2024
- Initiation Date
- March 1, 2021
- Classification Date
- February 22, 2024
- Termination Date
- March 6, 2025
- Address
- 24 Cherry Hill Dr, N/A, Danvers, MA, 01923-2575, United States
Description
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Reason
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
Code Info
Product Code 0042-0000-US UDI-DI 00813502010022; Product Code 0042-0010-US UDI-DI 00813502010985; Product Code 0042-0040-US UDI-DI 00813502011401; Software Versions V8.4 and V8.4.1
Distribution
US Nationwide distribution.
Quantity
4,463 (US)