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Health Canada Medical devices

OptiSite and Fem-Flex II Arterial Perfusion Cannulas

Issued June 18, 2025
Issue
Edwards has confirmed a small number of occurrences impacting the OptiSite Arterial Perfusion Cannula in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip, was found to be released from the cannula body. No customer complaints were reported in Canada. As certain femoral arterial cannula models are made of the same components as the impacted OptiSite Arterial Perfusion Cannula, the scope of this notice includes these femoral arterial cannula models. Recall start date: June 3, 2025
Hazard description
Performance
Product
Product name
OptiSite and Fem-Flex II Arterial Perfusion Cannulas
Reference
ID
RA-77622