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.

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