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Inspire

Inspire Medical Systems, Inc. · Model 900-007-008 · UDI-DI 10855728005656

MNQ Prescription

510(k) clearances

3,486

Adverse events (4 deaths)

Recalls

Facilities

Description

The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

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.