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Inspire Medical Systems Inc. recalls Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Prod
Recalled September 12, 2018 · FDA recall Z-2969-2018 · Inspire Medical Systems
Hazard
Incorrect use-by date on the device registration/patient file labels. · FDA Class II
Units
93 devices
Sold at
US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI.
Description
Incorrect use-by date on the device registration/patient file labels.
Product
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
Manufacturer(s)
Inspire Medical Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →