Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sen...
Reason for Recall / Hazard
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.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Golden Valley |
| State | MN |
| Event id | 98990 |
| Address 1 | 5500 Wayzata Blvd Ste 1600 |
| Code info | 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 |
| Postal code | 55416-1237 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 50 impacted units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260511 |
| Initial firm notification | Letter |
| Center classification date | 20260618 |
Overview
- Recalling FirmInspire Medical Systems Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the country of Hong Kong.