Inspire Respiratory Sensing Lead
Inspire Medical recalls Respiratory Sensing Lead Model 4340 due to incorrect Use By dates that may cause premature revision surgery.
Do not use the Inspire Respiratory Sensing Lead if the Use By date has passed or if the label appears incorrect. Contact Inspire Medical Systems for replacement or return instructions.
Why it was recalled
Inspire Medical Systems is recalling the Inspire Respiratory Sensing Lead (Model 4340) because the Use By date on the label is incorrect, extending beyond the validated three-year shelf life. Material degradation past the Use By date may lead to unplanned or premature revision surgery.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| 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 | 10855728005793, 10810098650295 | Z-2516-2026 |
| 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 | 10855728005946, 10810098650301 | Z-2515-2026 |
| 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 | – | – |
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification