FDA recall Z-0041-2025

Inspire Medical Systems Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-07-31
Report date
2024-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Golden Valley, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0041-2025