Medtronic Perfusion Systems: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622

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: 13,510 units Lot/code info: UDI-DI: 20763000135670, Lot Numbers: 0232601501 0232601510 0232601549 0232601550 0232602178 0232602290 0232602302 0232910952 0232910953 0232910954 0232910955 0233244075 0233244301 0233244531 0233286362 0233286374 0233286390 0233409034 0233416071 0233528731

UPC codes

20763000135670

Source

Official record: FDA (Device enforcement) ↗

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