Plymouth, MN, United States
MEDTRONIC ATS MEDICAL, INC. recalls
2 recalls recorded since 2018, most recently on 12 October 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 October 2020
- Terminated
- 16 August 2024
- Reason
- There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0495-2021, Z-0496-2021, Z-0493-2021, Z-0494-2021
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has a
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System.
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has
Terminated Class II Medical devices
- Recall started
- 11 February 2020
- Terminated
- 4 March 2022
- Reason
- 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.
- Distribution
- China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1533-2020
- Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.