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,
Inspire Medical Systems is recalling Model 3028 IV Implantable Pulse Generators because a manufacturing defect may cause electrical leakage in the sensing circuit. This requires revision surgery to replace the device, which is a serious medical procedure.
A manufacturing defect in the sensing circuit can cause electrical leakage, leading to system malfunction. This requires revision surgery to replace the implantable pulse generator, which is a significant medical procedure.
Patients with Inspire Model 3028 pulse generators are affected. Those who have the specific serial numbers listed in the US or Europe are most at risk.
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.
Your doctor will determine if revision surgery is needed to replace the device due to potential electrical leakage.
The recall does not require immediate discontinuation; you should contact your doctor to assess if revision surgery is needed.
The recalled model is Inspire Model 3028 IV Implantable Pulse Generator.
Check the serial numbers listed in the US or Europe sections of the recall notice.
We’ve drafted a message you can send Inspire Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2159-2024 — Inspire Medical Systems Inspire Medical Systems Hello, I own a Inspire Medical Systems that is covered by recall Z-2159-2024 from Inspire Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
