Inspire Model 3028 — Class I medical device recall Z-2159-2024
Ongoing recall by Inspire Medical Systems Inc., reported 2024-07-03, distributed nationwide. There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which ca
| Recall number | Z-2159-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inspire Medical Systems Inc., Golden Valley, MN, United States |
| Recall initiated | 2024-05-16 |
| Classified | 2024-06-21 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 24 devices |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10855728005847 |
| Serial numbers | AIR324492C, AIR324493C, AIR324494C, AIR324496C, AIR324497C, AIR324499C, AIR324500C, AIR324502C, AIR324503C, AIR324504C, AIR324505C, AIR324506C, AIR324507C, AIR324508C, AIR324509C, AIR324510C, AIR324511C, AIR324515C, AIR324517C, AIR324518C, AIR324520C, AIR324521C, AIR324522C, AIR324523C |
| Model numbers | 3028 |
Product
Inspire Model 3028, IV Implantable Pulse Generator
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,
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2159-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.