Recall Monitor
Health Products

Heartware Ventricular Assist System - Heartware Monitor

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Heartware Ventricular Assist System - Heartware Monitor
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Heartware Ventricular Assist System - Heartware MonitorMore than 10 numbers, contact manufacturer.1522CA
1521CA

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

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