The FDA has deemed the recall of the Medtronic Valiant Navion thoracic stent-graft system as Class I, the most serious kind.

Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta. It uses a long catheter to place the stent graft inside the aorta. The stent graft expands to fit within the aorta to provide a new path for blood to flow from the heart to the lower part of the body, according to an FDA news release.

Medtronic initiated the recall on Feb. 4, 2021,  in response to information it obtained from the Valiant Evo global clinical trial indicating that three patients had experienced stent fractures. Two had confirmed type IIIb endoleaks.

Read the full article at Medical Tubing & Extrusion.