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.

Inspire Medical Systems Inc. Medical Device Recall: Inspire Model 3028, IV Implantable Pulse Generator | SafeCheck