| TGA Action ID |
RC-2026-RN-00603-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Cardioroot Woven Grafts
Model Numbers: HEWROOT0024 , HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, HEWROOT0034 |
| ARTG Number |
343016 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Internal testing of samples from CARDIOROOT vascular grafts produced Integral Water Permeability (IWP) results outside the limit specified in the product’s Instructions for Use (IFU) (i.e. <5 ml/cm²/min). Given that the affected products did not meet the specified acceptance criteria for water permeability, they are out of specification and may pose risks to patient health. |
| Instructions for Customers/Users |
Customers should remove all affected product from inventory and quarantined immediately for return to the manufacturer.
Product distribution remains on hold until compliant products become available.
Please note that the implementation of this Urgent Recall may lead to temporary supply constraints, as compliant devices are not expected to be available in the short term. |
| Action Commencement Date |
13/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 438 464 Getinge Customer Service on or Quality.AUNZ@getinge.com |