The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious.
The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of the descending thoracic aorta.
There have been 11 reported issues, including two injuries and one death. Distribution dates were November 12, 2018 to February 10, 2021.
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