Medtronic Ats Medical, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Medtronic Ats Medical, Inc. makes
Medtronic Ats Medical, Inc. produces a Laser Angle Measurement Tool designed specifically for assessing open and closed leaflet angles, likely used in cardiac or vascular procedures.
This device is classified as Class III under FDA regulations and is listed under the Premarket Approval (PMA) pathway. The company is based in the United States.
Catalogue
- Regimes: PMA Registry: PMA
FDA recalls
FDA recall records list 5 recalls initiated by Medtronic Ats Medical, Inc., the earliest on 2020-02-11 and the most recent on 2020-10-12. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 5
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 12 Oct 2020 Z-0493-2021 Class II Terminated There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- 12 Oct 2020 Z-0494-2021 Class II Terminated There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- 12 Oct 2020 Z-0495-2021 Class II Terminated There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- 12 Oct 2020 Z-0496-2021 Class II Terminated There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- 11 Feb 2020 Z-1533-2020 Class II Terminated Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
Frequently asked questions
How many devices does Medtronic Ats Medical, Inc. have in the registry?
The registry currently lists 1 device for Medtronic Ats Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Ats Medical, Inc.'s devices?
Among its 1 most recently registered device, Medtronic Ats Medical, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Medtronic Ats Medical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Medtronic Ats Medical, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Medtronic Ats Medical, Inc.?
FDA recall records list 5 recalls initiated by Medtronic Ats Medical, Inc., the most recent initiated on 12 Oct 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medtronic Ats Medical, Inc. in the registry?
The most recently registered devices listed for Medtronic Ats Medical, Inc. include Laser Angle Measurement Tool for Open and Close Leaflet Angles Measurement.