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Inspire Medical Systems Recalls
6 recalls on record · September 12, 2018 to June 24, 2026 · Medical Devices
Recalls by year
18
24
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2026Medical DevicesFDA
Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product D
Hazard: 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 Date may result in unplanned or premature revision surgery.
June 24, 2026Medical DevicesFDA
Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 S
Hazard: 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 Date may result in unplanned or premature revision surgery.
October 16, 2024Medical DevicesFDA
Inspire Medical Systems Inc. recalls Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Hazard: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
October 16, 2024Medical DevicesFDA
Inspire Medical Systems Inc. recalls Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Hazard: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
July 3, 2024Medical DevicesFDA
Inspire Medical Systems Inc. recalls Inspire Model 3028, IV Implantable Pulse Generator
Hazard: 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 the IPG,
September 12, 2018Medical DevicesFDA
Inspire Medical Systems Inc. recalls Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Prod
Hazard: Incorrect use-by date on the device registration/patient file labels.