Heartmate Ii™ And Heartmate 3™ Left Ventricular Assist Systems

Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems Recall Thoratec Corporation is recalling Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems across Canada due to performance issues. These devices are mechanical pumps implanted in patients with serious heart conditions to help the heart pump blood. The recall affects all units of these devices that were distributed in Canada.

Product
Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2024-03-06
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/570b7e89-a251-4020-beef-94795473419b