Silk Road Medical Pulls More Lots of Stent System
Silk Road Medical has announced that it has voluntarily recalled additional lots of its Enroute transcarotid stent system.
The company, which initially recalled five lots on Jan. 13, has now withdrawn an additional 48 lots totaling approximately 1,800 products after receiving a further complaint of a tip detaching from the stent’s delivery system.
Silk Road said it has received a total of six complaints regarding the products since September. The company warned that a detached tip could cause serious injury or death but said it has not received reports of either.
The Enroute stents are manufactured by Florida-based Cordis, a Cardinal Health subsidiary.