The US Food and Drug Administration has designated Medtronic PLC’s recent recall of its Valiant Navion Thoracic Stent Graft System as high-risk class I.
It’s Class I For Medtronic’s Valiant Navion Recall
The US FDA gave its highest risk classification to a recent recall of the Valiant Navion Thoracic Stent Graft System. Two serious injuries and one death – a clinical trial participant – were reported.

More from Recalls
More from Policy & Regulation
As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.