# FDA 483 - MEDTRONIC ATS MEDICAL, INC. - January 15, 2026

Source: https://www.keypedia.com/records/483/medtronic-ats-medical-inc/c58f42a6-8c02-4a7b-b0e3-1a2d7fc70205

> FDA 483 for MEDTRONIC ATS MEDICAL, INC. on January 15, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MEDTRONIC ATS MEDICAL, INC.
- Inspection Date: 2026-01-15
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of MEDTRONIC ATS MEDICAL, INC. in Plymouth, MN, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions (CAPA) and for controlling nonconforming products. These issues indicate a lack of robust quality management practices.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/medtronic-ats-medical-inc/6cbc6189-9356-4752-8c34-57464444cbdb

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