Inspire Medical Systems recalls Inspire II Model 3024 Implantable Pulse Generator (IPG) units with incorrect use-by dates on registration labels. Affected units have serial numbers starting with NCR2022... or NCR2023...
Incorrect use-by date on the device registration/patient file labels.
Inspire Medical Systems is recalling Inspire II Model 3024 Implantable Pulse Generators (IPGs) for Obstructive Sleep Apnea that have incorrect use-by dates on their registration labels. This could lead to improper device management if the use-by date is not followed correctly.
The device registration labels contain an incorrect use-by date (2018-01-14) that could lead to improper management of the device if the use-by date is not followed correctly. This is a labeling issue rather than a safety hazard in normal use.
Patients with the Inspire Upper Airway Stimulation system who own the recalled IPG units with specific serial numbers. Healthcare providers who have these units in their inventory are also affected.
Check the device registration label set on the sterile tray/IPG box for the incorrect use-by date of 2018-01-14. Affected units have serial numbers starting with NCR2022... or NCR2023... as listed in the recall notice.
Look for the incorrect use-by date of 2018-01-14 on the device registration label set in the sterile tray/IPG box.
The recall is due to incorrect use-by dates on the device registration labels, which could lead to improper management of the device if the use-by date is not followed correctly.
Check the device registration label set for the incorrect use-by date of 2018-01-14. If you have the affected serial numbers listed in the recall notice, contact Inspire Medical Systems for further instructions.
This is a labeling issue that does not pose a safety risk in normal use. The hazard is low risk as it only affects device management and not the device's safety.
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-2969-2018 — Inspire Medical Systems Inspire Medical Systems Hello, I own a Inspire Medical Systems that is covered by recall Z-2969-2018 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.
