Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.