Cardioroot
- Recalling firm
- Getinge Australia Pty Ltd (NZ)
- Product
- Cardioroot. [Device]. Model: CARDIOROOT Woven - Model number: HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, HEWROOT0034. Affected: All CARDIOROOT Woven products within labelled shelf life
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-18
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/fb396cc2-2b48-484a-984e-97480f240ad0