Inspire respiratory sensing leads labeled with Use By dates beyond shelf life
Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where an overstated expiry date could allow implantation of degraded material, with a stated risk of revision surgery and no injuries reported.
Plain-English summary
The Inspire Respiratory Sensing Lead, model/catalog number 4340, from Inspire Medical Systems, Inc., is being recalled. The action covers 50 impacted units, UDI-DI 10855728005946.
The products are labeled with an incorrect Use By Date, extending beyond the validated three-year shelf life from the date of manufacture. According to the manufacturer, material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States and to Hong Kong. The leads are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI-DI and part numbers in the recall notice, quarantine it, and follow the instructions issued by Inspire Medical Systems.
The recalled product
- 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 pres
- Manufacturer
- Inspire Medical Systems Inc.
- Hazard
- labeling-error
- expiry-overstated
- material-degradation
- revision-surgery
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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