HeartWare Ventricular Assist System (2018-03-22)

Starting date:

March 22, 2018

Posting date:

April 6, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals

Identification number:

RA-66378

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  Reason
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  Affected products

Affected products

HeartWare Ventricular Assist System

Reason

This recall is being initiated to address the customer notification, training and product retrieval for the previous generation HeartWare Ventricular Assist Device (HVAD) System Controller which will initiate the launch plan for a new version of the HVAD controller (also referred to as controller 2.0)  manufacturer has developed an updated HeartWare HVAD System Controller as part of continuous improvement initiatives following two previously communicated urgent field safety notices that occurred in April 2015 and April 2016. With the introduction of the updated HVAD controller, manufacturer is initiating removal procedures for previous generation HeartWare HVAD Controllers. The removal of these HVAD controllers will occur concurrently with the introduction of the new HVAD controller.

Affected products