Inspire Respiratory Sensing Lead
Inspire is recalling its Respiratory Sensing Lead (Model 4340) due to incorrect Use By Dates that may lead to premature revision surgery.
If you have an Inspire Respiratory Sensing Lead (Model 4340) with an incorrect Use By Date, stop using it and contact Inspire Medical Systems for instructions on returning the product and obtaining a replacement.
Why it was recalled
Inspire Medical Systems is recalling the Inspire Respiratory Sensing Lead (Model 4340) because the products are labeled with an incorrect Use By Date, extending beyond the validated three-year shelf life. Material degradation of the lead past its Use By Date may result in 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.
Inspire Medical Systems, Inc. Inspire
| Product | Lot code | Recall # | UDI-DI | Model/Catalog number |
|---|---|---|---|---|
| stimulation Lead | – | Z-2516-2026 | 10855728005793, 10810098650295 | 4063 |
| Respiratory Sensing Lead | 4340 | Z-2515-2026 | 10855728005946, 10810098650301 | 4340 |
| stimulation Lead | 4063 | – | 4063, 10855728005793, 10810098650295 | 4063 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Labeling Error recalls
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification