Class I — Inspire Medical Systems Inc.
| Recalling firm | Inspire Medical Systems Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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, |
| Product | Inspire Model 3028, IV Implantable Pulse Generator |
| Quantity | 24 devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Germany. |
| Initiated | 2024-05-16 |
| Classified | 2024-06-21 |
| Recall number | Z-2159-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Inspire Medical Systems Inc. (Z-2159-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94658/
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