OptiSite and Fem-Flex II Arterial Perfusion Cannulas
Brand(s)
Last updated
Summary
Product
OptiSite and Fem-Flex II Arterial Perfusion Cannulas
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| OptiSite Arterial Perfusion Cannula | More than 10 numbers, contact manufacturer. | OPTI18 |
| OptiSite Arterial Perfusion Cannula | More than 10 numbers, contact manufacturer. | OPTI16 |
| Fem-Flex II Femoral Arterial Cannula | More than 10 numbers, contact manufacturer. | FEMII016A |
| Fem-Flex II Femoral Arterial Cannula | More than 10 numbers, contact manufacturer. | FEMII016AS |
| Fem-Flex II Femoral Arterial Cannula | More than 10 numbers, contact manufacturer. | FEMII018A |
| Fem-Flex II Femoral Arterial Cannula | More than 10 numbers, contact manufacturer. | FEMII018AS |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Edwards Lifesciences LLC
1 Edwards Way, Irvine, California, United States, 92614
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77622
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