Official recall notice

FDA DeviceClass IINotable

Medtronic GUNDRY Retrograde Cannula Recall (May 2026)

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

Recall date
2026-05-27
FDA class
Class II

Why it was recalled

Hazard

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

One email a week when there are new recalls. Confirm by email; unsubscribe anytime.

Product description

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

Verify with the official notice →
Share:

Related Recalls

2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass a
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return ca
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass a
Medtronic Perfusion Systems