Automated Impella Controller Software Issue Prevents Pump Detection
Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. Devices were distributed in Arizona, California, Florida, New York, and Virginia.
- Product
- Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
- Category
- Medical Device
- Distribution
- 5 states