Inspire Medical Systems recalls Model 4340 Respiratory Sensing Leads with incorrect Use By Dates that could lead to unplanned revision surgery. Affected units have specific serial numbers and were sold in the US. Consumers should contact the company for details.
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Inspire Medical Systems is recalling its Model 4340 Respiratory Sensing Leads because they have an incorrect Use By Date that extends beyond the three-year shelf life. This could cause material degradation and lead to unplanned revision surgery if the product is used past its expiration.
The leads have an incorrect Use By Date that extends beyond the validated three-year shelf life. Over time, material degradation can occur, which may cause the device to malfunction and require unplanned revision surgery.
Patients with Inspire Respiratory Sensing Leads (Model 4340) who have the listed serial numbers are affected. Those who have the product installed and are using it are at risk of needing revision surgery if the device degrades.
Check if your Inspire Respiratory Sensing Lead has the model number 4340 and one of the listed serial numbers (e.g., T18806, T45012, T91485). These units were sold in the US and may have been purchased between 2019 and 2022.
Look for the serial number on the lead, which should match one of the listed numbers (e.g., T18806, T45012, T91485).
Reach out to Inspire Medical Systems for specific instructions on whether your unit needs revision surgery.
The Inspire Respiratory Sensing Leads have an incorrect Use By Date that extends beyond the validated three-year shelf life, which could lead to material degradation and unplanned revision surgery.
No, but you should check if your unit has the listed serial numbers and contact Inspire Medical Systems for guidance on whether revision surgery is needed.
If your lead has the listed serial numbers, you may need revision surgery due to material degradation from using it past its expiration date.
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-2515-2026 — Inspire Medical Systems Inspire Medical Systems Hello, I own a Inspire Medical Systems that is covered by recall Z-2515-2026 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.
