Medtronic Perfusion Systems — Class II: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardi
Medtronic Perfusion Systems has initiated a Class II recall for certain lots of the Medtronic DLP Retrograde Cannula (Model 94725) due to a potential breach in the sterile barrier.
This recall affects Medtronic Perfusion Systems and healthcare providers utilizing manual-inflate silicone body retrograde cannulae during cardiopulmonary bypass procedures.
A sterile barrier breach compromises the aseptic nature of the device, which may increase the risk of infection in surgical settings. Regulatory teams should view this as a failure of packaging integrity or manufacturing controls, potentially requiring an investigation into seals, transport durability, or material compatibility to prevent recurrence.
QA and supply chain teams should immediately identify and quarantine specific lots of Model 94725. Conduct a thorough review of sterile barrier integrity testing and packaging validation protocols to identify potential failure modes in manual-inflate silicone catheters.
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 94725; Cardiopulmonary bypass vascular catheter. Firm: Medtronic Perfusion Systems (Brooklyn Park MN United States). Status: Ongoing.
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