FDA-Device2021-03-17Class I
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Medtronic Vascular, Inc.
Hazard
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
Sold states
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, Belgium, Saudi Arabia, Malaysia, Singapore, Brazil, Macau, Luxembourg, Viet Nam, Taiwan, Croatia, Serbia, United Arab Emirates, Slovenia, Philippines, Poland, Japan, Costa Rica, Hungary, Korea, Slovakia, Malta, Bahrain, Kuwait, Qatar, Reunion, Honduras, Mauritius, India, Peru, El Salvador, Ukraine, Uruguay, Trinidad and Tobago.
Affected count
33,430 units
Manufactured in
3850 Brickway Blvd, Santa Rosa, CA, United States
Products
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1201-2021Don't want to check this manually?
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