Class II

Medical Device Recall: Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Inspire Medical Systems Inc. · July 31, 2024

Reason for Recall

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.

States Affected

NATIONWIDE

Quantity Affected

457 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0041-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.