Heartware Ventricular Assist System - Hvad Implant Kit (2020-04-06)

HeartWare Ventricular Assist System (HVAD) Recall HeartWare is recalling HVAD implant kits distributed across Canada due to a defect that could cause the device to stop working unexpectedly. The recall affects ventricular assist systems used to support heart function in patients who need the device. This is classified as a Class I recall, meaning the most serious type where there is potential for serious injury or death.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-05-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/213e4218-bcab-499e-9a71-db37c269cb70