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Inspire

Inspire Medical Systems, Inc. · Model 900-014-005 · UDI-DI 10810098650301

MNQ Prescription
0
510(k) clearances
3,571
Adverse events (4 deaths)
6
Recalls
15
Facilities

Description

The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.

Recalls

DateFirmReason
2026-05-11Inspire 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
2026-05-11Inspire 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
2024-07-31Inspire 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.
2024-07-31Inspire 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.
2024-05-16Inspire 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
2018-06-12Inspire 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.