Edwards Pascal Transcatheter Mitral Valve Repair System - Guide Sheath (2018-03-05)

Recall Summary Edwards PASCAL Transcatheter Mitral Valve Repair System Guide Sheaths are being recalled across Canada due to a medical device issue. The Guide Sheath is a component used during minimally invasive heart valve repair procedures. This is a Class I recall, which is the most serious classification.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-04-06

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a1f9b556-7fd1-4c60-9958-0b9486279127