Health Canada — Medical Devices · Canada · 2015-07-17 · Type II
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Reported risk: Through June 4, 2015, Medtronic has received five reports in which the user observed the barbs were backwards on the connector of DLP Femoral Arterial Cannula. The users had difficulty or were unable to connect the Cannula to the Perfusion Circuit Tubing. No adverse patient impacts were reported. While the risk remains low, potential harm resulting from a difficult connection may include delayed or prolonged procedure, trauma to patient's vasculature or blood loss.
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