Early Alert: Thoracic Stent Graft Issue From Bolton Medical

Bolton Medical is alerting healthcare providers about thoracic stent grafts that may fail to detach from their delivery system during implantation. This malfunction could require emergency open surgery and has been associated with patient deaths. The recall affects thoracic stent grafts distributed by Bolton Medical.

Recalling firm

Bolton Medical

Product

Thoracic Stent Graft

Reason

Affected grafts may not unclasp from the delivery system, which may require conversion to open surgical repair and can result in patient death

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-04-28

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/6e1c1073-c970-4447-a38c-a45d0620f38f