HeartWare™ Ventricular Assist Device (HVAD™) System – Availability of controller with unapproved software and patient management recommendation for power source

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited, as a follow-up to their earlier communications in January 2021, July 2021, March 2022 and October 2022, regarding the HeartWare™ Ventricular Assist Device (HVAD™) System, to update healthcare professionals that Medtronic has developed an alternate pump start algorithm within the controller software that may help restart pumps which cannot be restarted with the standard controller. Although the controller software with the alternative algorithm is unapproved and limited testing has been conducted, some patients may have no alternative options for support if the standard controller fails to restart the pump. These controllers will have additional labelling to differentiate them from a standard controller. Healthcare professionals are advised to inform Medtronic if a controller specifically programmed with the unapproved software is required for use in circumstances where a patient’s standard back-up controller is unable to restart his or her pump. 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.