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Inspire Model 4063 Stimulation Lead
No active recall
FDA product code: MNQ · Category: Stimulator, Hypoglossal Nerve, Implanted, Apnea
Severity Snapshot
1,169 total reports2016-06 – 2026-03 date range93.5% physician / facility reported6.5% manufacturer reported1 SKU variants
Reporting Trend
Annual Reporting Volume
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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.
Reported Events
Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.
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