Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Inspire Medical Systems Inc Inspire Model 3028, IV Implantable Pulse Generator [HKMD number: 240043].
According to the FDA, 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.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94658
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Jun 2024