FDA 483 - Anteris Technologies Ltd - February 20, 2025

Anteris Technologies Ltd, a specification developer and complaint handling establishment in Eagan, MN, was cited for failing to submit Medical Device Reports (MDRs). The firm did not report five complaints regarding their CardioCel and VascuCel cardiovascular patches leaking, which could compromise product sterility and potentially lead to serious injury if the malfunction recurred. This indicates a significant regulatory non-compliance regarding post-market surveillance.