| TGA Action ID |
RC-2026-RN-00464-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae
EOPA 3D Arterial Cannula
Model Numbers: 78222 & 78322
Lots: 0232612916, 0233245850, 0233245860, 0232862787
EOPA Elongated One-Piece Arterial Cannula
Model Numbers: 77422, 77522, 77622, 77722
Multiple Lot Numbers |
| ARTG Number |
148990, 148991 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. The leaks were identified either prior to use or during active bypass flow. Evaluation of returned devices confirmed the presence of a small pinhole defect located near the 5th–6th spring wire coil beyond the final depth marking on the cannula body. This condition may not be visible during routine inspection and is typically only detectable when the cannula is flexed.
As of May 13, 2026, Medtronic has received 35 reports associated with this condition, representing an estimated occurrence rate of approximately 0.10%. Potential risks associated with this condition may include hypovolaemia, vessel laceration or perforation, hypotension, ischaemia, and organ dysfunction. No adverse patient outcomes have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Immediately identify and quarantine all unused affected product.
- Complete the Customer Response Form and follow instructions for returning affected product.
- Consider the alternatives outlined in the Customer Letter, as clinically appropriate.
Medtronic expects to begin receiving initial recovery lots within the next 8-10 weeks, with full recovery expected between late September and early October 2026, depending on specific device production. |
| Action Commencement Date |
22/06/2026 |
| Responsible Entity |
|
| Contact Information |
0428 464 838 - Azi Hosseini |