HeartWare HVAD Controller: Translation Errors in Critical Documentation
The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.
- Product
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
- Category
- Medical Device
- Distribution
- 0 states