FDA Device recall Z-2159-2024
Inspire Model 3028, IV Implantable Pulse Generator
- FDA Device
- Class I
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class I recall of Inspire Model 3028, IV Implantable Pulse Generator by Inspire Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2159-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-16 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Inspire Medical Systems |
| Distribution | US |
Product
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,
Identifiers
| code_info | US: UDI/DI 0855728005915, Serial Numbers: AIR324492C, AIR324500C, AIR324506C, AIR324510C, AIR324518C, AIR324523C, AI…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2159-2024%22
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