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FDAMay 16, 2024device

Inspire Model 3028, IV Implantable Pulse Generator

Official recall recorded by the U.S. Food & Drug Administration.

The 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,

What to do

FDA enforcement status: Ongoing

Brands named

inspire medical systemsinspireinspire medical

UPCs

085572800591510855728005847

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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