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Health Canada Medical devices

Heartware Ventricular Assist System

Issued February 14, 2022
Issue
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 battery). The pins of the power source connectors are coated with a deoxit lubricant that should not be removed, as it is intended to help prevent unexpected power switching. power switching can occur when there are transient interruptions to the electrical connection with the HVAD system power sources. Recall start date: Jan 31, 2022
Hazard description
Revised instructions for use
Product
Product name
Heartware Ventricular Assist System
Reference
ID
RA-63926