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Inspire

Inspire Medical Systems, Inc. · Model 900-003-020 · UDI-DI 00855728005437

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510(k) clearances

3,486

Adverse events (4 deaths)

Recalls

Facilities

Description

The Model 3024 Inspire II 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 connects to the stimulation lead and sensing lead. The IPG has multiple programmable parameters that can be adjusted for a particular patient. Adjustments may be made to the sensing circuits to vary the timing of stimulation pulses and to the stimulation circuits to adjust the energy and duration of stimulation pulses. These adjustments provide the ability to optimize the opening of the upper airway. Based on typical settings from the STAR pivotal trial the longevity of the IPG’s battery will average 10 years. The Model 3024 IPG was originally developed by Medtronic and utilizes the same platform as Medtronic’s Itrel® 3 IPG which is FDA approved for other neurostimulation therapies. Figure 9 provides a photograph of the Model 3024 IPG.

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.