Edwards Pascal Transcatheter Valve Repair System (2019-06-04)

Edwards PASCAL Transcatheter Valve Repair System Recall Edwards PASCAL Transcatheter Valve Repair System devices have been recalled across Canada. The devices are used to repair heart valves through a catheter-based procedure. The recall is classified as Class I, indicating a serious issue with the device.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-06-28

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/84a295f3-3cae-4e8c-9ca8-3c2e4aa9837d