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Inspire

Inspire Medical Systems, Inc. · Model 900-002-005 · UDI-DI 00855728005000

MNQ Prescription
0
510(k) clearances
3,486
Adverse events (4 deaths)
6
Recalls
15
Facilities

Description

The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration.

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.