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Inspire

Inspire Medical Systems, Inc. · Model 900-001-008 · UDI-DI 10855728005397

MNQ Prescription

510(k) clearances

3,486

Adverse events (4 deaths)

Recalls

Facilities

Description

The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.

Recalls

Date	Firm	Reason
2026-05-11	Inspire Medical Systems Inc.	Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D
2026-05-11	Inspire Medical Systems Inc.	Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D
2024-07-31	Inspire Medical Systems Inc.	Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
2024-07-31	Inspire Medical Systems Inc.	Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
2024-05-16	Inspire Medical Systems Inc.	There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace t
2018-06-12	Inspire Medical Systems Inc.	Incorrect use-by date on the device registration/patient file labels.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.