Medtronic Voluntarily Pulls Thoracic Stent Grafts

Medtronic has issued a worldwide recall of all unused Medtronic Valiant Navion thoracic stent graft systems as it investigates potential safety concerns.

The company said it initiated the recall because three patients treated with the device experienced stent fractures in a global clinical trial and one patient death was reported.

A further review by an independent imaging laboratory found that seven of 87 patients were observed to have stent ring enlargement beyond the design specification. The company is conducting a comprehensive root cause investigation.