FDA DeviceClass IINotable

FDA Recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmona

Date: 2026-05-27
Brand: Medtronic Perfusion Systems
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

6572 units

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