| TGA Action ID |
RC-2026-RN-00665-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VentStar Resus Neo and VentStar Resuscitaire
VentStar Resus Neo
Part Number: MP00310
VentStar Resuscitaire
Part Number: MP00311 |
| ARTG Number |
372390 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Draeger have become aware of cases in which obvious cracks in the hose of the VentStar Resus Neo and VentStar Resuscitaire were detected by the users prior to use. In no case we were informed of any negative effects on the health of the affected patients. However, this cannot be completely ruled out if such crack remains undetected.
In case a cracked hose is used, the hose could fall off or leakage will occur. Depending on the leak, ventilation will be restricted and therapy could be delayed potentially resulting in desaturation, hypoxia or patient death.
Draeger analyses revealed that affected hoses developed cracks shortly after the manufacturing and assembly process. Stress tests on “flawless” hoses have shown that they can safely be used as always. |
| Instructions for Customers/Users |
Customers are advised:
1. Carefully inspect the hoses for damages prior to use according to the product’s Instructions for Use (IfU).
2. Discard products that show cracks or have a detached hose.
All other products can be used safely. |
| Action Commencement Date |
4/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 372 437 - Customer service |