ProductGuru Recalls

Official recall record

OptiSite and Fem-Flex II Arterial Perfusion Cannulas

Health Canada — Medical Devices · 2025-06-18 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2025-06-18
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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