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
Inspire Medical Systems Inc.
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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 identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Lot Code: Model No 4340 (USA only lead)Model UDI-DI [4340] 10855728005946Model Inspire part number [4340] 900-014-003Model serial numbers T18806Model T45012Model T45017Model T49002Model T67098Model T67152Model T69541Model T69542Model T69553Model T69558Model T69562 Model No 4340 (Global lead)Model UDI-DI [4340] 10810098650301Model Inspire part number [4340] 900-014-005Model serial numbers T91485Model T91486Model T91491Model T91495Model T91513Model T91520Model T91521Model T91527Model T91533UPC 10855728005946UPC 10810098650301Would you have heard about this one?
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