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Optisite and fem-flex ii arterial perfusion cannulas
Official notice
18 Jun 2025
Last checked
18 Jun 2025
An official Health Canada notice concerns Optisite and fem-flex ii arterial perfusion cannulas. 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 Published 2025-06-18.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77622
Official notice
2025-06-18
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Edwards Lifesciences, Optisite And Fem-flex Ii Arterial Perfusion Cannulas.
Source & status
Source & status
Source
Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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