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Open, Classified

Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

FDA Recall Z-0041-2025 · Posted 2024-10-09

Recalling FirmInspire Medical Systems Inc.
Recall StatusOpen, Classified
Product CodeMNQ
Date Initiated2024-07-31
Product Quantity457 units

Reason for Recall

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Firm Action

Inspire notified consignees on 07/31/2024, via emailed letter. Consignees were instructed to confirm the serial number on the lead is the serial number used to register the patient and to contact your Inspire representative if any labeling inconsistency is identified for complaint reporting.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.

Official Source

View FDA Recall →

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

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