Automated Impella Controller software error affects left ventricular support devices
Automated Impella Controllers are being recalled because of a potential software error when used with left ventricular Impella devices. 10,297 units are affected.
- Product
- Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.
- Category
- Medical Device
- Distribution
- Distributed nationwide