Heartware Ventricular Assist System

Heartware Ventricular Assist System Recall Summary The Heartware Ventricular Assist System, a heart pump device, is being recalled across Canada due to revised instructions for use. This is classified as a Class I recall, meaning there is a serious potential health hazard. The recall affects patients and healthcare providers using this device throughout Canada.

Product
Heartware Ventricular Assist System
Reason
Revised instructions for use
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2022-02-14
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/14514c7e-e94c-4082-948d-a9409e49ad55