Inspire Medical Systems Inc.: Device Recall

Recall #Z-0041-2025 · 07/31/2024

Class II: Risk

Recall Details

Recall Number: Z-0041-2025
Classification: Class II
Product Type: Device
Recalling Firm: Inspire Medical Systems Inc.
Status: Ongoing
Date Initiated: 07/31/2024
Location: Golden Valley, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 457 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.

Product Description

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

Distribution Pattern

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

Other Recalls by Inspire Medical Systems Inc.

Class II: Risk 07/31/2024

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Class I: Dangerous 05/16/2024

There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

View all recalls by Inspire Medical Systems Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.