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Medtronic Cardiovascular Surgery-the Heart Valve Division
FDA Regulatory Profile
Summary
- Total Recalls
- 4 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2546-2016 | Class II | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. De | August 3, 2016 |
| Z-2264-2015 | Class I | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. | July 15, 2015 |
| Z-2623-2014 | Class II | Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in c | August 15, 2014 |
| Z-0908-2014 | Class II | Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the | January 9, 2014 |