Item 7.01. Regulation FD Disclosure.

We are voluntarily recalling 288 units of our ENROUTE® Transcarotid Stent System, or ENROUTE SDS, based on five reports we received related to the tip of the stent delivery system becoming detached in five TCAR procedures. These reports were made between September 2020 and January 2021 and we have commenced an investigation into this matter.

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