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It’s Class I For Medtronic’s Valiant Navion Recall

 
• By Shawn M. Schmitt

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.

Sign of Medtronic at Canada Headquarters in Brampton, Ontario, Canada.

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.

The agency says the device was recalled because of “stent fractures and endoleak concerns.” Two serious injuries and one death – a clinical trial participant – were reported.

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