Inspire Medical Systems Inc.: Device Recall

Recall #Z-2159-2024 · 05/16/2024

Class I: Dangerous

Recall Details

Recall Number: Z-2159-2024
Classification: Class I
Product Type: Device
Recalling Firm: Inspire Medical Systems Inc.
Status: Ongoing
Date Initiated: 05/16/2024
Location: Golden Valley, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24 devices

Reason for Recall

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,

Product Description

Inspire Model 3028, IV Implantable Pulse Generator

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Germany.

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 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.

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.