CLASS I ONGOING Device recall · Reported 3 Jul 2024 · FDA Enforcement Report
Inspire Model 3028, IV Implantable Pulse Generator recalled
Inspire Medical Systems is recalling Inspire Model 3028, IV Implantable Pulse Generator, distributed nationwide in the US. The recall was initiated on 16 May 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2159-2024
- FDA event ID
- 94658
- Recalling firm
- Inspire Medical Systems, Golden Valley, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 16 May 2024
- FDA classified
- 21 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 16 May 2024 | Recall initiated by company | |
| 21 Jun 2024 | Classified by FDA | +36 days |
| 3 Jul 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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,
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Inspire Model 3028, IV Implantable Pulse Generator
Where it was distributed
Worldwide distribution - US Nationwide and the country of Germany.
Questions about this recall
Why was it 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,
Which lots 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
Where was it sold?
Worldwide distribution - US Nationwide and the country of Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Inspire Medical Systems
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Inspire Respiratory Sensing Lead recalled by Inspire Medical Systems | Inspire Medical Systems | Potency & Assay | Nationwide |
| Device | CLASS II | Inspire stimulation Lead recalled by Inspire Medical Systems | Inspire Medical Systems | Potency & Assay | Nationwide |
| Device | CLASS II | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled | Inspire Medical Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Inspire Model 4340 Respiratory Sensing Lead recalled | Inspire Medical Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Inspire II recalled by Inspire Medical Systems | Inspire Medical Systems | Other | Nationwide |
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