Heartware Ventricular Assist System - Heartware Controller (2018-08-29)
HeartWare Ventricular Assist System Recall HeartWare Controllers used with the HeartWare Ventricular Assist System are being recalled in Canada due to a potential device malfunction. The HeartWare Controller is a component that monitors and manages a heart pump device used to support heart function in patients with advanced heart failure. This recall affects HeartWare Controllers that were distributed across Canada.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-09-28
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1f00bb83-346e-4524-bbaf-ec09cfbf7b3a