Inspiris Resilia Aortic Valve

Recalling firm

Edwards Lifesciences (New Zealand) Limited

Product

INSPIRIS RESILIA Aortic Valve. [Device]. Affected: Patient Implant Cards (PIC) previously provided; Patient Implant Cards (PIC) previously provided; Patient Implant Cards (PIC) previously provided.; Patient Implant Cards (PIC) previously provided; Patient Implant Cards (PIC) previously provided.; Patient Implant Cards (PIC) previously provided.; Patient Implant Cards (PIC) previously provided.; Patient Implant Cards (PIC) previously provided.. Also covers: Magna Ease 3300TFX; SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve system; KONECT RESILIA Aortic Valved Conduit; MITRIS RESILIA...

Reason

Edwards Lifesciences has identified an error on certain Patient Implant Cards (PIC) previously provided. The errors may relate to incorrect models, size or serial numbers, or a combination of these., This error is only associated with the implant card information and has no impact on the function of the implanted device.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-02-18

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/d5b253ef-474b-46a1-8347-1cc1bc5b4d39