Heartware Ventricular Assist System
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or Serial Number |
Model or catalog number |
|---|---|---|
Heartware Ventricular Assist System - Heartware Battery |
More than 10 numbers, contact manufacturer. |
1650DE |
Heartware Ventricular Assist System - Heartware Controller |
More than 10 numbers, contact manufacturer. |
1403US, 1407CA |
Heartware Ventricular Assist System - Heartware Controller Dc Adapter Controller |
More than 10 numbers, contact manufacturer. |
1440 |
Heartware Ventricular Assist System – Heartware Controller Ac Adapter |
More than 10 numbers, contact manufacturer. |
1430CA |
Issue
While performing a review of product literature, including the instructions for use (IFU) and patient manual (PM), It was identified that additional clarity was required around cleaning the power source connectors (controller AC adapter, DC adapter, and battery). The pins of the power source connectors are coated with a deoxit lubricant that should not be removed, as it is intended to help prevent unexpected power switching. power switching can occur when there are transient interruptions to the electrical connection with the HVAD system power sources.
Recall start date: Jan 31, 2022
Additional information
Details
Heartware Inc.
14400 Nw 60th Avenue, Miami Lakes, Florida
United States, 33014
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