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Heartware ventricular assist system - heartware monitor
Official notice
16 Jan 2025
Last checked
16 Jan 2025
An official Health Canada notice concerns Heartware ventricular assist system - heartware monitor. 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 Published 2025-01-16.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76836
Official notice
2025-01-16
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Heartware, Heartware Ventricular Assist System - Heartware Monitor.
Source & status
Source & status
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Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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