Silk Road Medical recalls Enroute stent system due to part detachment

Silk Road Medical Inc. is voluntarily recalling 288 units of its Enroute Transcarotid Stent System due to the tendency of the instrument's tip to detach.

The Sunnyvale, Calif.-based medical device company said in an SEC filing that it has been informed about incidents where the tip of the Enroute heart stent detached in five transcarotid artery revascularization procedures. The incidents were reported between September 2020 and January 2021.

Silk Road said it has started an investigation into the matter.