Recall Z-1201-2021— Medtronic Vascular, Inc.
Class I · Ongoing
Class I FDA medical device recall by Medtronic Vascular, Inc., initiated 2021-02-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).. Reason: Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement..
- Recalling firm
- Medtronic Vascular, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-02-12
- Firm location
- Santa Rosa, CA, United States
Product description
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Reason for recall
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
Data sourced from openFDA. This site is unofficial and independent of the FDA.