FDA recall Z-0441-2024
Abiomed, Inc. · Class II · device
Product
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
US: AZ, CA, FL, NY & VA.
Key facts
- Status
- Terminated
- Initiation date
- 2023-10-10
- Report date
- 2023-12-13
- Termination date
- 2025-03-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Danvers, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0441-2024