Inspire Model 3028, IV Implantable Pulse Generator
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Inspire Medical Systems Inc.
- 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,
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Inspire Model 3028, IV Implantable Pulse Generator
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2159-2024
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