On-x Conform-x Prosthetic Heart Valve - Aortic With Extended Valve Holder, Mitral, Aortic And On-x Prosthetic Heart Valve - Aortic, Mitral, On-x Prosthetic Heart Valve - Aortic With Extended Valve H

Recall Summary On-X brand prosthetic heart valves (used in aortic and mitral valve replacement surgeries) are being recalled in Canada due to potential manufacturing defects that could affect valve durability and function. The recall includes several On-X valve models with different configurations and holder types. This affects patients who have received these specific valve models.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-04-24

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/44c6cfc7-080a-4eb9-bee6-ca010115e6bb