MEDTRONIC ATS MEDICAL, INC.
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0494-2021 | Class II | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - i | October 12, 2020 |
| Z-0495-2021 | Class II | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is | October 12, 2020 |
| Z-0493-2021 | Class II | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - P | October 12, 2020 |
| Z-0496-2021 | Class II | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - | October 12, 2020 |
| Z-1533-2020 | Class II | Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm | February 11, 2020 |