# FDA 483 - Atrium Medical Corporation - November 26, 2024

Source: https://www.keypedia.com/records/483/atrium-medical-corporation/e5f6f83a-1e7e-48dc-b0a6-bbfb1c0edcf4

> FDA 483 for Atrium Medical Corporation on November 26, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Atrium Medical Corporation
- Inspection Date: 2024-11-26
- Product Type: device
- Office Name: New England District Office
- Summary: Atrium Medical Corporation received an FDA Form 483 citing significant quality system deficiencies across multiple areas. The inspection revealed inadequate design verification for their iCast and Advanta V12 stents, leading to component separation and patient deaths, alongside failures in environmental controls and nonconforming product procedures for various sterile medical devices. Furthermore, the firm demonstrated systemic issues with its corrective and preventive action system, and critically, failed to timely investigate and report numerous complaints and Medical Device Reports (MDRs) related to serious injuries and device malfunctions.

## Related Documents

- [WARNING_LETTER - 2012-09-07](https://www.keypedia.com/records/warning_letter/atrium-medical-corporation/b7b52ef0-39cd-4e26-bdf6-92606930f3e7)
- [483 - 2018-08-02](https://www.keypedia.com/records/483/atrium-medical-corporation/738cb61e-bd80-40f6-955a-a7ec15a16c71)
- [483 - 2020-02-10](https://www.keypedia.com/records/483/atrium-medical-corporation/c1f59260-0cd9-499d-b4b1-9217859385ad)
- [483 - 2022-09-06](https://www.keypedia.com/records/483/atrium-medical-corporation/9f765a95-4914-4fc6-837e-c626f60ec74d)

## Related Officers

- [Diane M. Biron](https://www.keypedia.com/people/diane-m-biron/12eb885a-3ae3-449d-907e-36133dbdb194)
- [CSO at FDA](https://www.keypedia.com/people/justine-m-corson/5f6e4477-f060-47f1-9165-a63fd6a36226)

Company: https://www.keypedia.com/companies/atrium-medical-corporation/a210e43f-6ec7-4e83-83ee-1650b1cedd35

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144