Documentation errors recalled in HeartWare HVAD instructions and manuals
Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.
- Product
- Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are dist
- Category
- Medical Device
- Distribution
- Distributed nationwide