Product Wiki · Recalls · Health Canada — Medical Devices

OptiSite and Fem-Flex II Arterial Perfusion Cannulas — recall 77622

Health Canada — Medical Devices · Canada · 2025-06-18 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
77622
Date of alert
2025-06-18
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/optisite-and-fem-flex-ii-arter

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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