Inspire recall
Inspire Model 3028, IV Implantable Pulse Generator
Why was Inspire recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Inspire Model 3028, IV Implantable Pulse Generator
- Recalling firm
- Inspire Medical Systems Inc.
- Quantity
- 24 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Germany.
- Recall date
- July 3, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)