HeartWare HVAD System Controller Recalled for Translation Errors in Documentation
Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.
- Product
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
- Category
- Medical Device
- Distribution
- 0 states