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

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution. Quantity: 1,424 units Lot/code info: UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787

UPC codes

20199150023251, 00199150023257

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.