Medtronic Heartware Ventricular Assist Device System - Recall Due To Risk Of Neurological Adverse Events, Mortality And Delay Or Failure To Restar

Medtronic HeartWare Ventricular Assist Device Recall Medtronic is recalling HeartWare Ventricular Assist Device Systems in Canada because the devices carry a risk of neurological adverse events, mortality, and potential delays or failure to restart. These devices are implanted to help the heart pump blood in patients with advanced heart failure. The recall affects HeartWare systems distributed across Canada.

Reason
Medical devices - Product safety
Category
drug recall
Country
Canada
Agency
HC-DRUGS
Recall date
2021-06-25
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DRUGS

Recall details on Nibble Recalls: https://trynibble.app/recalls/aeaeed99-d2d7-4daa-b237-793f760c7df8