Updated failure rates and additional data on subset of implanted Medtronic HeartWare™ Ventricular Assist Device Systems (HVAD™) with potential delay or failure of pump restart

A Dear Healthcare Professional Letter has been issued by Medtronic International Ltd, as a follow‐up to their earlier communications in January 2021 and July 2021, to update healthcare professionals on the failure rates of the subset of implanted Medtronic HeartWare^™ Ventricular Assist Device (HVAD) Systems with potential delay or failure of pump restart, as well as to provide additional data to assist in clinical decision-making. Within the original subset of affected devices, Medtronic has identified two distinct subgroups from specific pump impeller component manufacturing lots that have exhibited differing failure rates and provided their model and serial numbers in the letter. Healthcare professionals are advised to make treatment decisions for patients with the affected pumps on a case-by-case basis and to speak with their patients with affected devices to emphasize avoidance of unnecessary pump stops. Healthcare professionals are also advised to follow the updated patient management recommendations detailed in the letter. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.