Lead Recall: Inspire Respiratory Sensing 4340
Announced 2026-06-24 · FDA
The FDA recall covers the Inspire Respiratory Sensing Lead (Model 4340) due to incorrect Use By Date labeling that extends beyond the validated three-year shelf life. Material degradation past the Use By Date may result in unplanned or premature revision surgery. Fifty units are implicated and distributed worldwide, including the US and Hong Kong.
| Brand | Inspire Medical Systems Inc. |
|---|---|
| Product | 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 |
| Reason | 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. |
| Severity | moderate |
| Units affected | 10 |
| Distribution | Worldwide distribution - US Nationwide and the country of Hong Kong. |
| Agency | FDA |
| Recall / campaign no. | Lot Code: Model No 4340 (USA only lead); UDI-DI [4340] 10855728005946; Inspire part number [4340] 900-014-003; serial numbers T18806, T45012, T45017, T49002, T67098, T67152, T69541, T69542, T69553, T69558, T69562 Model No 4340 (Global lead); UDI-DI [4340] 10810098650301; Inspire part number [4340] 900-014-005; serial numbers T91485, T91486, T91491, T91495, T91513, T91520, T91521, T91527, T91533, T91537, T91540, T91545, T96165, T96168, T96192, T96193, T96195, T96225, T96237, T98118, T98126, T98136, T98137, T98138, T98141, T98143, T98145, T98150, T98153, T98156, T98163, T98165, T98176, T98177, T98178, T98181, T98183, T98190, T96217 |
WHAT YOU SHOULD DO
- Check whether you have an Inspire Respiratory Sensing Lead 4340.
- Contact your healthcare provider or Inspire Medical Systems for guidance on the Use By Date and potential replacement.
- Do not use or implant any devices past their Use By Date.
- If you have an affected unit, arrange for evaluation or replacement through your clinician.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.