Edwards Pascal Transcatheter Valve Repair System (2019-04-28)

Edwards PASCAL Transcatheter Valve Repair System Recall Edwards PASCAL Transcatheter Valve Repair System devices have been recalled across Canada. The recall is classified as Class I, which is the most serious type. The specific reason for the recall relates to the medical device itself, though detailed technical information about the defect is not provided in this notice.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-05-24
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/cc88dd60-b67e-4bcb-861b-8b0f631c63a8