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 Abbott Medical Apical Coring Knife and HeartMate 3 LVAD Kits [Models: 1050, 106524INT; GTIN: 00813024010227, 00813024011712] [HKMD No.: 180052].
According to the MHRA, starting in April 2023, the manufacturer has received complaints regarding inability of the Apical Coring Knife to start and/or complete resecting heart tissue when the physician was preparing the patient’s heart for implantation of the Left Ventricular Assist Device (LVAD). The Apical Coring Knife is used during implantation of the HeartMate 3 LVAD to cut through the myocardium when the surgeon creates the apical ventriculotomy for the implantation of the LVAD into the left ventricle. Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife could result in an extended procedure or surgical time while the backup coring knife is acquired. No patient injury or harm has been reported, but potential additional risks include a remote risk of hemodynamic compromise and/or thromboembolism/thromboembolic event, and improbable risk of stroke and/or death.
For further information, please visit https://mhra-gov.filecamp.com/s/d/Op3kXlRXyaQxSFqE
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 Aug 2023