Recall Z-1201-2021 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Medtronic Vascular, Inc.
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
| Date | Feb 12, 2021 |
| Status | Open, Classified |
| Reason | Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. |
| Root cause | Under Investigation by firm |
| Action | On or about 02/12/2021, the Recalling Firm initiated global verbal notifications to customers (risk managers and physicians) to immediately cease implants and quarantine any unused affected products. |
| Quantity | 33,430 units |
| Distribution | Worldwide distribution. US Nationwide, Italy, Denmark, Germany, Finland, Chile, Russian Federation, Norway, South Africa, New Zealand, Australia, United Kingdom, Switzerland, Austria, Netherlands, Spain, Portugal, France, Israel, Greece, Thailand, Ireland, Colombia, Canada, Hong Kong, Sweden, Belgi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.