| TGA Action ID |
RC-2025-RN-00498-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Optisite Arterial Cannula & Femoral Arterial Cannula
Product Codes:
ECV-OPTI16 - OPTISITE ARTERIAL PERFUSION CANNULA 16FR
ECV-OPTI18 - OPTISITE ARTERIAL PERFUSION CANNULA 18FR
ECV-FEMII016A - FEM-FLEX II FEM ART CANNULA VENTED 16FR
ECV-FEMII018A - FEM-FLEX II FEM ART CANNULA VENTED 18FR
All non-expired lot numbers
ARTG's: 334633 & 358110 |
| ARTG Number |
334633, 358110 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer 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.
As certain Femoral Arterial Cannula models are made of the same components as the impacted OptiSite Arterial Perfusion cannula, the scope of this recall includes these Femoral Arterial Cannula models.
In the small number of occurrences of this problem the released wire at the tip of the cannula was identified prior to any procedures being performed. The complaints have not resulted in any injury. The risk for the wire-reinforcement coil protruding out of the cannula body is major tissue damage and haemolysis. |
| Instructions for Customers/Users |
Do not use and quarantine affected stock to prevent further use.
Device Technologies will contact customers to arrange the collection of the affected devices and reconcile this recall.
No patient follow-up or notification is necessary.
DTA have advised that there is currently no available, unaffected stock of the four product codes subject to this recall, and the manufacturer expects that supply of unaffected devices will be delayed until September 2025.
This action has been closed out on 18/05/2026 |
| Action Commencement Date |
6/06/2025 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 – Device Technologies Customer Service |