FDAFDA · Food and drugs·Recall number Z-2159-2024
Inspire Model 3028, IV Implantable Pulse Generator
Published July 3, 2024 · Recall initiated: May 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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,
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Inspire Medical Systems Inc.
- Distributor
- Worldwide distribution - US Nationwide and the country of Germany.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States