Inspire Medical Systems Inc.: Medical Device Recall in 2024 - (Recall #: Z-2159-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Inspire Model 3028, IV Implantable Pulse Generator

Product Classification:

Class I

Date Initiated: May 16, 2024

Date Posted: July 3, 2024

Recall Number: Z-2159-2024

Event ID: 94658

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,

Status: Ongoing

Product Quantity: 24 devices

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

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Germany.

Voluntary or Mandated:

Voluntary: Firm initiated