Heartware Ventricular Assist System Hvad - Implant Kit

HeartWare Ventricular Assist System (HVAD) Implant Kit Recall HeartWare's HVAD implant kit is being recalled across Canada because the device can stop working unexpectedly due to a firmware issue. This affects patients who have received or may receive this heart-assist device, which is used to help pump blood in people with severe heart failure. The recall is classified as Class I, which is the most serious level.

Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2016-08-22
Status
Closed
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1ad87c05-7297-4f66-ba74-79bd29b74cca