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 Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Thoratec Corporation [Abbott Medical] HEARTMATE 3 LVAS KITS & HEARTMATE 3 OUTFLOW GRAFTS and HEARTMATE II LVAS KITS & HEARTMATE II OUTFLOW GRAFTS [HKMD number: 100551, 180052].
According to the MHRA, the manufacturer has planned to update the Instructions for Use associated with observed outflow graft deformation known as “Extrinsic Outflow Graft Obstruction” (EOGO) associated with the HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II LVAS. Significant EOGO will manifest clinically as a persistent low flow alarm under certain circumstances in some patients, and in such cases, may impair the ability of the HeartMate LVAS to provide adequate hemodynamic support.
For further information, please visit
MHRA: https://mhra-gov.filecamp.com/s/d/wZKN8GczQ2snXidB
TGA: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00125-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Feb 2024
Updated on 29 Feb 2024