Medtronic Heart Valves Division
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2041-2021 | Class II | CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N; | June 11, 2021 |
| Z-2043-2021 | Class II | CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US; | June 11, 2021 |
| Z-2042-2021 | Class II | CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; | June 11, 2021 |
| Z-0559-2021 | Class II | Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR- | October 23, 2020 |
| Z-0561-2021 | Class II | Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV E | October 23, 2020 |
| Z-0560-2021 | Class II | Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVO | October 23, 2020 |