Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Inspire Model 3028 Recalled by Inspire Medical Systems Inc. Due to There is a potential manufacturing defect which can...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Inspire Medical Systems Inc. directly.
Affected Products
Inspire Model 3028, IV Implantable Pulse Generator
Quantity: 24 devices
Why Was This Recalled?
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,
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Inspire Medical Systems Inc.
Inspire Medical Systems Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report