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Inspire

Inspire Medical Systems, Inc. · Model 900-029-001 · UDI-DI 00810098650038

MNQ Prescription

510(k) clearances

3,571

Adverse events (4 deaths)

Recalls

Facilities

Description

The Model 2740S SleepSync Programmer Application is a standalone software that is downloaded and installed on a user-owned computer and paired by the user (clinician) with the Model 2740C Programmer Cable to non-invasively interrogate and program the Implantable Pulse Generator (IPG) of the Inspire Upper Airway Stimulation (UAS) System. The SleepSync Programmer Application provides the graphic user interface (GUI) for the SleepSync Programmer System (Model 2740S and Model 2740C) while the Programmer Cable provides the communications interface between the SleepSync Programmer Application and the IPG. The SleepSync Programmer Application has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

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.