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 Abiomed Europe GmbH Impella Catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. [HKMD numbers: 180162, 180163, 210434].
According to the FDA, IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93749
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 15 Feb 2024
Updated on 26 Feb 2024