Use cautionMedical device recall · FDA · Published May 16, 2024
Inspire Model 3028 Pulse Generator Recall: Electrical Leakage Risk
Inspire Medical Systems recalls Model 3028 IV Implantable Pulse Generator due to potential electrical leakage causing system malfunction and requiring revision surgery. Affected units have specific serial numbers in the US and Europe.
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,
Take action
Contact the company
📍Recalling firmInspire Medical Systems Inc.5500 Wayzata Blvd Ste 1600 · Golden Valley, MN 55416-1237
“Inspire Model 3028 Pulse Generator Recall: Electrical Leakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55071-inspire-model-3028-pulse-generator-recall-electrical-leakage-risk. Based on FDA recall #Z-2159-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2159-2024%22&limit=1).
The FDA announced on May 16, 2024, that Inspire Medical Systems Inc. is recalling Inspire Model 3028 IV Implantable Pulse Generators due to a potential manufacturing defect causing electrical leakage and system malfunction. The agency classified the recall as Class I.
How to tell if you have it
Brand: Inspire
Product: Inspire Model 3028, IV Implantable Pulse Generator
Europe Serial Numbers: AIR324497C, AIR324499C, AIR324505C
Units affected: 24 devices
The hazard
A potential manufacturing defect can lead to electrical leakage in the sensing circuit, which causes a system malfunction and requires revision surgery to replace the IPG.
Context
GovInfoNow's records show Inspire Medical Systems Inc. has 3 other recalls on record since 2018-06-12. Other recent recalls of similar products include Olymp ShockPulse-SE Lithotripsy System Generator Recall (2025-11-14), GE Medical Systems Allia IGS 3 Pulse X-Ray System Recall (2026-04-20), and Philips Allura Xper FD10C Medical System Recall (2025-12-15).
How to tell if you have this one
Check if your device has the specific serial numbers listed in the US (e.g., AIR324492C) or Europe (e.g., AIR324497C). The device is an IV Implantable Pulse Generator used for medical treatment.
Brand
Inspire Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Your Doctor
Your doctor will determine if revision surgery is needed to replace the device due to potential electrical leakage.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2159-2024 (May 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2159-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.