Reported Jun 24, 2026 · Ongoing
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340…
Inspire Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inspire Medical Systems Inc. · 5500 Wayzata Blvd Ste 1600 · Golden Valley, MN · 55416-1237
Is this the product you have?
- Brand NameInspire Medical Systems, Inc
- Product NameInspire Respiratory
- Sensing Lead Model/Catalog Number4340
- Software VersionN/A
- Product DescriptionThe 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)
- ComponentN/A
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published 4340Lot Code: (USA only lead) — 10855728005946UDI-DI [4340] 10855728005946 — Inspire part number [4340] 900-014-003 4340serial numbers T18806, T45012, T45017, T49002, T67098, T67152, T69541, T69542, T69553, T69558, T69562 (Global lead) — 10810098650301UDI-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 - Amount recalled
- 50 impacted units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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