Home / Recalls / Inspire Medical Systems Inc. / Z-2159-2024

Z-2159-2024 Class I Ongoing

Recalled by Inspire Medical Systems Inc. — Golden Valley, MN

Recall Details

Product Type
Devices
Report Date
July 3, 2024
Initiation Date
May 16, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 devices

Product Description

Inspire Model 3028, IV Implantable Pulse Generator

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,

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Germany.

Code Information

US: UDI/DI 0855728005915, Serial Numbers: AIR324492C, AIR324500C, AIR324506C, AIR324510C, AIR324518C, AIR324523C, AIR324493C, AIR324502C, AIR324507C, AIR324511C, AIR324520C, , AIR324494C, AIR324503C, AIR324508C, AIR324515C, AIR324521C, AIR324496C, AIR324504C, AIR324509C, AIR324517C, AIR324522C; Europe: UDI/DI 10855728005847, Serial Numbers: AIR324497C, AIR324499C, AIR324505C

Other recalls by Inspire Medical Systems Inc.

  • Z-0040-2025 Class II — Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airw (July 31, 2024)
  • Z-0041-2025 Class II — Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimu (July 31, 2024)
  • Z-2969-2018 Class II — Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Ap (June 12, 2018)