Class I

Medical Device Recall: Inspire Model 3028, IV Implantable Pulse Generator

Inspire Medical Systems Inc. · May 16, 2024

Reason for Recall

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,

Distribution

Worldwide distribution - US Nationwide and the country of Germany.

States Affected

NATIONWIDE

Quantity Affected

24 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2159-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.