Edwards Sapien Xt Transcatheter Heart Valve With Novalex Delivery System & Accessories (2016-07-25)

Edwards SAPIEN XT Transcatheter Heart Valve Recall Edwards Lifesciences is recalling the SAPIEN XT Transcatheter Heart Valve with Novaflex Delivery System and related accessories across Canada due to a device malfunction issue. This is a Class I recall, which means the device could cause serious injury or death. The recall affects heart valve devices that were distributed throughout Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-08-05

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0372414a-a37a-4e0e-906b-b06d2375cfcc