Health Canada — Medical Devices · Canada · 2015-04-27 · Type II
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Reported risk: Through post market surveillance, Edwards Lifesciences has identified a potential health risk to patients regarding the use of Fem-Flex II femoral arterial cannula, sizes 8, 10, and 12 French only. Edwards has received one customer complaint regarding a released wire, located at the tip area of the cannula, which was identified prior to use. Although the condition does not affect the functionality of the cannula, there is potential patient safety risk if a protruding wire is not detected prior to use.
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