# FDA 483 - Anteris Technologies Ltd - February 20, 2025

Source: https://www.globalkeysolutions.net/records/483/anteris-technologies-ltd/75858b91-bada-4e36-8882-f36454d581d3

> FDA 483 for Anteris Technologies Ltd on February 20, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Anteris Technologies Ltd
- Inspection Date: 2025-02-20
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Albert L. Nguyen](https://www.globalkeysolutions.net/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.globalkeysolutions.net/companies/anteris-technologies-ltd/e06d6339-387b-41ab-91a1-77fc56bdc783

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d