Edwards Sapien 3 Ultra Transcatheter Heart Valve System (2019-07-04)

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Recall The Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System has been recalled across Canada. This is a medical device used in heart valve replacement procedures. The recall was classified as Class I, which is the most serious type.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-07-16

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/bebe3c13-fe18-4781-9715-2076782f49df