Health product recall

Heartware Ventricular Assist System

Brand(s)
Last updated

Summary

Product
Heartware Ventricular Assist System
Issue
Medical devices - Revised instructions for use
What to do

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
Original published date: 2022-02-16
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Health product - Medical device - General hospital and personal use
Companies

Heartware Inc.

14400 Nw 60th Avenue, Miami Lakes, Florida

United States, 33014

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63926