Product Wiki · Recalls · Health Canada — Medical Devices

Heartware Ventricular Assist System - Heartware Monitor — recall 76836

Health Canada — Medical Devices · Canada · 2025-01-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76836
Date of alert
2025-01-16
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heartware-ventricular-assist-s

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