FDA Enforcement
Class I
Ongoing
Inspire Model 3028, IV Implantable Pulse Generator
Recall: Z-2159-2024
·
Reported July 3, 2024
Enforcement
- Recall Number
- Z-2159-2024
- Event ID
- 94658
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Inspire Medical Systems Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 3, 2024
- Initiation Date
- May 16, 2024
- Classification Date
- June 21, 2024
- Address
- 5500 Wayzata Blvd Ste 1600, Golden Valley, MN, 55416-1237, United States
Description
Inspire Model 3028, IV Implantable Pulse Generator
Reason
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,
Code Info
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
Worldwide distribution - US Nationwide and the country of Germany.
Quantity
24 devices