| TGA Action ID |
RC-2025-RN-00648-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DLP Left Heart Vent Catheter
Model Numbers: 12110, 12113, 12115 |
| ARTG Number |
289357 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Medtronic is recalling the DLP Left Heart Vent Catheter following complaints of catheters resisting shape retention when being bent.
The investigation found that the removal of the annealing step in the 304 stainless steel wire within the catheter to be the potential root cause. Annealing is a critical process which enables shape retention properties of the wire. |
| Instructions for Customers/Users |
Medtronic has corrected the problem for newly manufactured lots.
Customers are to be aware there will be limited product availability for these items over the next few months, and may need to work with sales representative to explore potential replacement options that Medtronic can offer.
If a suitable replacement is unavailable, Medtronic will issue a credit note. |
| Action Commencement Date |
5/08/2025 |
| Responsible Entity |
|
| Contact Information |
0428 464 838 - Azi Hosseini, Medtronic Australasia |