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 number: 180162, 180163, 210434].
According to the FDA, new warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93746
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