Inspire Medical Systems Inc
Golden Valley, MN, US
INSPIRE MEDICAL SYSTEMS INC appears in FDA device records in Golden Valley, MN. FDA records list no 510(k) clearances, 132 PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007666314 | 3007666314 | INSPIRE MEDICAL SYSTEMS INC | 5500 Wayzata Blvd. Suite 1600, Golden Valley, MN 55416 US | 2026 | |
| 3030499299 | 3030499299 | Inspire Medical Systems Inc | 6105 Golden Hills Drive, Suite 100, Golden Valley, MN 55416 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2516-2026 | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A | 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. | Class II | Open, Classified | |
| Z-2515-2026 | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product 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 implantable pulse generator (IPG). Component: N/A | 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. | Class II | Open, Classified | |
| Z-0041-2025 | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. | Class II | Open, Classified | |
| Z-0040-2025 | Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system. | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. | Class II | Open, Classified | |
| Z-2159-2024 | Inspire Model 3028, IV Implantable Pulse Generator | 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, | Class I | Open, Classified | |
| Z-2969-2018 | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA). | Incorrect use-by date on the device registration/patient file labels. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain