Heartware Ventricular Assist System - Heartware Monitor
Brand(s)
Last updated
Summary
Product
Heartware Ventricular Assist System - Heartware Monitor
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Heartware Ventricular Assist System - Heartware Monitor |
More than 10 numbers, contact manufacturer. |
1522CA |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
| Heartware Inc. |
| 14400 Nw 60th Avenue, Miami Lakes, Florida, United States, 33014 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76836
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