FDA-Device2024-10-16Class II
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Inspire Medical Systems Inc.
Hazard
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Sold states
Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
Affected count
457 units
Manufactured in
5500 Wayzata Blvd Ste 1600, Golden Valley, MN, United States
Products
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0041-2025Don't want to check this manually?
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