Product Wiki · Recalls · Health Canada — Medical Devices

HeartWare Ventricular Assist System (2018-03-22) — recall 60807

Health Canada — Medical Devices · Canada · 2018-04-06 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
60807
Date of alert
2018-04-06
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heartware-ventricular-assist-s

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