Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37310 |
| Brand Name: | Cardioroot |
| Model: | CARDIOROOT Woven - Model number: HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, HEWROOT0034 |
| Affected: | All CARDIOROOT Woven products within labelled shelf life |
| Software version: | |
| Recalling Organisation: | Getinge Australia Pty Ltd (NZ) Unit D, Ground Floor, Building A, Millenium Centre 600 Great South Rd Ellerslie Auckland 1051 |
| Contact Information: | 09 272 9039 |
| Manufacturer: | Intervascular SAS |
| Issue: | 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. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/8/2026 |
