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Inspire Medical Systems Inc. recalls Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Recalled October 16, 2024 · FDA recall Z-0040-2025 · Inspire Medical Systems
Hazard
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. · FDA Class II
Units
152 units
Sold at
Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
Description
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Product
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Manufacturer(s)
Inspire Medical Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →