HeartWare Ventricular Assist System Recalled for Driveline Connector Pin Retraction
HeartWare Inc is recalling HVAD systems due to complaints about pin retraction within the driveline connector. The recall affects 3,747 units currently in use worldwide.
- Product
- HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
- Category
- Medical Device
- Distribution
- 32 states