What LivaNova PLC told the SEC could break it.

A significant number of LivaNova's Cardiopulmonary products and component parts are sourced and produced outside the U.S., including in Italy and Germany, then sold into the U.S. (its largest market at 53% of net revenue). The imposition of tariffs and changes to global trade policies could therefore raise its cost of imported finished devices and components; the company states the impact is uncertain in the evolving trade-policy environment.

“In addition, the impact that the imposition of tariffs and changes to global trade policies could have on the Company's results of operations is uncertain. A significant number of LivaNova's Cardiopulmonary products and component parts are sourced and produced outside of the U.S., including in Italy and Germany.”

For quality-assurance, sole-source-availability, or cost reasons, LivaNova procures certain components and raw materials from a single supplier. It specifically flags the fiber used in the manufacture of its products (a critical input for cardiopulmonary oxygenators) as exposed to supplier shortages and interruptions; for single-sourced components it may not be able to establish new supply sources quickly or at all, which would impair its ability to meet market demand and manufacture products on time.

“supplier shortages and interruptions of certain components, such as the fiber used in the manufacture and marketing of LivaNova's products, the Company may not be able to establish new supply sources quickly or at all in response to a supply reduction or interruption, especially for components and raw materials sourced from a single supplier, resulting in negative effects on its ability to meet market demand and to manufacture products effectively and timely.”