Medtronic Perfusion Systems — Class II: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Card
Medtronic Perfusion Systems has initiated a Class II recall for specific lots of the Medtronic DLP Retrograde Cannula (Model 94215T) due to a potential breach in the sterile barrier. The recall is currently classified as ongoing.
This affects Medtronic Perfusion Systems and healthcare facilities utilizing the 15FR manual-inflate silicone body retrograde cannulas for cardiopulmonary bypass procedures. Quality, clinical operations, and supply chain departments are primarily impacted.
A sterile barrier breach represents a compromised state for a vascular catheter, potentially introducing pathogens directly into the bloodstream during bypass procedures. From a regulatory perspective, this suggests a failure in the integrity of the primary packaging or the validated sterilization process for these specific lots. Regulatory teams should anticipate potential deep-dives into packaging validation data if this indicates a systemic rather than isolated manufacturing issue.
Identify and quarantine affected Model 94215T lots immediately. QA teams should evaluate the root cause of the sterile barrier breach to determine if it stems from primary packaging design, manufacturing processes, or transit vulnerabilities. Ensure all field safety notices are documented and distributed to clinical end-users.
Class II. Reason: Certain lots of product have the potential for a sterile barrier breach.. Product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter. Firm: Medtronic Perfusion Systems (Brooklyn Park MN United States). Status: Ongoing.
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