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Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number

Recalled August 5, 2026 · FDA recall Z-2811-2026 · Medtronic Perfusion Systems

Hazard
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. · FDA Class II
Units
1,424 units
Sold at
Worldwide - US Nationwide distribution.

Description

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 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Manufacturer(s)
Medtronic Perfusion Systems

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Medtronic Perfusion Systems recalls EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number | RecallWatchUSA