Inspire Medical Systems recalls Model 4063 stimulation leads with incorrect Use By Dates that may lead to unplanned surgery. Affected units have specific serial numbers and were sold in the US. Contact for remedy 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 Model 4063 stimulation leads because they have incorrect expiration dates that could lead to unplanned surgery. This risk occurs when the leads degrade past their valid shelf life.
The leads have an incorrect expiration date that extends beyond the three-year shelf life. When the leads degrade past this date, they could cause unplanned or premature revision surgery.
Patients using Inspire stimulation leads with Model 4063 (serial numbers D53393, D61104, D89539, D89540, etc.) in the US. Those with the leads may face unplanned surgery if the leads degrade past their expiration date.
Check for Model 4063 stimulation leads with serial numbers D53393, D61104, D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959 in the US. These units were sold with incorrect expiration dates.
Look for serial numbers D53393, D61104, D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959 on the lead.
The leads have an incorrect expiration date that extends beyond the three-year shelf life, which could lead to unplanned surgery if the leads degrade past this date.
Check the serial number on your lead. If it matches the listed numbers, contact Inspire Medical Systems for further instructions.
Yes, if the leads degrade past their expiration date, they could cause unplanned or premature revision surgery.
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-2516-2026 — Inspire Medical Systems Inspire Medical Systems Hello, I own a Inspire Medical Systems that is covered by recall Z-2516-2026 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.
