Recall MonitorHealth Products
OptiSite and Fem-Flex II Arterial Perfusion Cannulas
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
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
Recall class: Type II
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