Medtronic Perfusion Systems — Class II: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardi
Medtronic Perfusion Systems has initiated a Class II recall for specific lots of the Medtronic DLP Retrograde Cannula (Model 94913) due to the potential for a sterile barrier breach. The recall remains ongoing.
This affects Medtronic Perfusion Systems, healthcare providers utilizing cardiopulmonary bypass vascular catheters, and hospital departments managing sterile surgical inventory.
A breach in the sterile barrier compromises the aseptic nature of the device, which poses a risk of infection or inflammatory response during surgical procedures. For regulatory and QA professionals, this suggests a possible deficiency in packaging design or manufacturing controls. The Class II designation implies that while the risk of serious adverse health consequences is not immediate, the product fails to meet essential safety requirements for sterile devices.
QA teams should immediately verify inventory against the specific model number (94913) and affected lots to isolate non-conforming product. Regulatory departments should ensure recall documentation is maintained for post-market surveillance audits, while procurement units should coordinate with the manufacturer for replacement stock to prevent clinical disruption.
Class II. Reason: Certain lots of product have the potential for a sterile barrier breach.. Product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter. Firm: Medtronic Perfusion Systems (Brooklyn Park MN United States). Status: Ongoing.
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