Open, Classified

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

FDA Recall Z-1201-2021 · Posted None

Recalling FirmMedtronic Vascular, Inc.

Recall StatusOpen, Classified

Product CodeMIH

Date Initiated2021-02-12

Product Quantity33,430 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.