EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Medtronic Perfusion Systems
The 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 recall.
The remedy
Follow FDA guidance
About this recall
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI: 20199150023251Model UDI-DI: 00199150023257Model Lot Numbers: 0232862787UPC 20199150023251UPC 00199150023257Would you have heard about this one?
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