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Displaying 1 - 4 of 4 items.
Heartware Ventricular Assist System - HVAD Implant Kit
Controller driveline cover of HVAD system may become hardened, creating difficulty or an inability to slide the cover back to access the drive line to control the connector. Access to the driveline connector may be delayed, which may result in patient…
RecallHealth product recall | 2022-12-16
Heartware Ventricular Assist System – Heartware Battery
Medtronic is informing customers of product performance issues related to the Heartware Ventricular Assist Device (HVAD) system batteries. Medtronic is taking actions to address two separate battery issues: 1) a weld nonconformance has been identified…
RecallHealth product recall | 2022-07-04
HVAD Implant Kit
Pump thrombosis caused by weld defect that allowed moisture into the center post and corroded the magnets that keep the impeller rotating concentrically.
Recall start date: April 26, 2022
RecallHealth product recall | 2022-05-30
Heartware Ventricular Assist System
While performing a review of product literature, including the instructions for use (IFU) and patient manual (PM), It was identified that additional clarity was required around cleaning the power source connectors (controller AC adapter, DC adapter, and…
RecallHealth product recall | 2022-02-14