Medtronic Vascular, Inc. recalls Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).

Recalled March 17, 2021 · FDA recall Z-1201-2021 · Medtronic Vascular

Hazard

Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. · FDA Class I

Units

33,430 units

Sold at

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.

Description

Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

Product

Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).

Manufacturer(s)

Medtronic Vascular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →