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Inspire Medical Systems Inc. recalls Inspire Model 3028, IV Implantable Pulse Generator
Recalled July 3, 2024 · FDA recall Z-2159-2024 · Inspire Medical Systems
Hazard
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, · FDA Class I
Units
24 devices
Sold at
Worldwide distribution - US Nationwide and the country of Germany.
Description
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,
Product
Inspire Model 3028, IV Implantable Pulse Generator
Manufacturer(s)
Inspire Medical Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →