Official recall record
Heartware Ventricular Assist System - Heartware Monitor
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-01-16
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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