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Health Canada Medical devices

Heartware Ventricular Assist System - Heartware Monitor

Issued January 16, 2025
Issue
If steps for programming an HVAD controller are not followed correctly and a patient's driveline is connected to a controller that was not powered down after programming, the pump will not restart and could lead to patient harm. It is recommended to power down the programmed controller and disconnect the monitor data cable before performing a controller exchange. Recall start date: January 8, 2025
Hazard description
Performance
Product
Product name
Heartware Ventricular Assist System - Heartware Monitor
Reference
ID
RA-76836