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Inspire

Inspire Medical Systems, Inc. · Model 900-004-031 · UDI-DI 00855728005109

MNQ Prescription

510(k) clearances

3,486

Adverse events (4 deaths)

Recalls

Facilities

Description

The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer.

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.