Medtronic is recalling its Valiant Navion Thoracic Stent Graft System as a result of stent fractures and endoleak concerns. After the device is implanted, the following may occur: Stent ring enlargement beyond the design specification, stent fractures, holes in the graft fabric, life-threatening bleeding, aortic rupture or death.
The Class I recall affects more than 14,000 devices that were distributed between November 12, 2018 and February 10, 2021. Thus far there have been 11 reported device issues, including two injuries and one death.
Medtronic sent an Urgent Medical Device Recall notification to affected customers on February 12, 2021 that urged them to immediately stop using the stent graft system and return unused products to the company.