Inspire Medical Systems Inc. recalls Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product…
- Recall date
- June 12, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2969-2018
- FDA classification
- Class II
- Brand / firm
- Inspire Medical Systems Inc.
- Sold / distributed
- 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.
Why it was recalled
Incorrect use-by date on the device registration/patient file labels.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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).
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