Medtronic Perfusion Systems — Class II: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; C
Medtronic Perfusion Systems has initiated a Class II recall for specific lots of the Medtronic GUNDRY Retrograde Cannula due to a potential breach in the sterile barrier.
This affects Medtronic Perfusion Systems, healthcare facilities utilizing retrograde cannulas for cardiopulmonary bypass, and personnel responsible for surgical inventory and sterile processing.
A breach in a device's sterile barrier poses a risk of microbial contamination, which can lead to serious patient infections during invasive cardiac procedures. From a regulatory perspective, this suggests a potential failure in packaging design, manufacturing environment controls, or distribution durability that may require CAPA intervention to prevent recurrence.
Affected organizations should immediately identify and sequester the specific model/lots indicated to prevent clinical use. Quality teams should review incoming inspection protocols for sterile barrier integrity and prepare for potential Root Cause Analysis documentation regarding packaging durability.
Class II. Reason: Certain lots of product have the potential for a sterile barrier breach.. Product: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter. Firm: Medtronic Perfusion Systems (Brooklyn Park MN United States). Status: Ongoing.
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