FDA WARNING_LETTER - Lexion Medical Llc - June 22, 2021

The FDA issued a Warning Letter to Lexion Medical LLC on July 26, 2021, for marketing adulterated and misbranded devices, including those related to COVID-19. The devices in question are the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE Gas Evacuation Cannula.

The FDA determined, based on a review of the firm's website and social media as recent as June 22, 2021, that these devices are adulterated because Lexion Medical LLC lacks an approved premarket approval (PMA) or investigational device exemption (IDE) for their current marketing. They are also misbranded for failure to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act.

Specifically, the AP 50/30 Insufflator and Insuflow Port, though cleared for basic insufflation, are promoted with uncleared claims such as reducing cell desiccation, hypothermia, postoperative pain, and subcutaneous emphysema. The Pneuview XE, cleared for smoke and plume evacuation, is promoted with uncleared claims of eliminating "all" plume, gases, particles, contaminants, and viruses, including viral particles, and eliminating unsafe negative pressure. The FDA states there is no evidence to support these claims and that such promotion may lead to patient harm.

Furthermore, the