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Open, Classified

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

FDA Recall Z-2515-2026 · Posted 2026-06-18

Recalling FirmInspire Medical Systems Inc.
Recall StatusOpen, Classified
Product CodeMNQ
Date Initiated2026-05-11
Product Quantity50 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.

Firm Action

Firm began notifying consignees on May 11, 2026. Letters were titled "URGENT Medical Device Correction." The firm requests consignees' assistance in removing affected product from clinical inventory and returning them to Inspire.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Hong Kong.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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