Heartware Ventricular Assist System - Heartware Monitor
Heartware Monitor Recall Summary The Heartware Monitor, part of the Heartware Ventricular Assist System used to support heart function in patients, is being recalled across Canada due to a performance issue. This is classified as a Class I recall, meaning there is a potential serious adverse health consequence. The device is distributed nationwide in Canada.
- Product
- Heartware Ventricular Assist System - Heartware Monitor
- Reason
- Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2025-01-16
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/765fbf13-d13f-4188-a483-05031ee052a3