Medtronic Perfusion Systems — Class II: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmon
Medtronic Perfusion Systems has initiated a Class II recall for the EOPA Elongated One-Piece Arterial Cannula (Model 77722) due to the potential for pinhole leaks in the wire-wound body during use.
Medtronic Perfusion Systems, healthcare facilities using arterial return cannulas in cardiopulmonary bypass, and personnel responsible for perfusion and surgical equipment management.
A breach in the integrity of the cannula body during bypass procedures presents significant clinical risks, including hypovolemia and organ dysfunction. From a regulatory perspective, this suggests a potential failure in material integrity or manufacturing processes that necessitates immediate field action to mitigate patient harm.
Verify current inventory for Model 77722, ensure the recall notification is distributed to clinical users, and review manufacturing/QA records for potential wire-winding process deviations that could result in pinhole defects.
Class II. Reason: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.. Product: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722. Firm: Medtronic Perfusion Systems (Brooklyn Park MN United States). Status: Ongoing.
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