Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Reported: March 17, 2021 Initiated: February 12, 2021 #Z-1201-2021
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.
Details
- Recalling Firm
- Medtronic Vascular, Inc.
- Units Affected
- 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, 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.
- Location
- Santa Rosa, CA
Frequently Asked Questions
What product was recalled? ▼
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).. Recalled by Medtronic Vascular, Inc.. Units affected: 33,430 units.
Why was this product recalled? ▼
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 17, 2021. Severity: Critical. Recall number: Z-1201-2021.
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