Potential delay or failure of pump restart with a subset of implanted Medtronic HeartWare™ Ventricular Assist Device (HVAD™) Systems

A Dear Healthcare Professional Letter has been issued by Medtronic International Ltd to inform healthcare professionals of a potential delay or failure of pump restart with a subset of implanted Medtronic HeartWare^™ Ventricular Assist Device (HVAD^™) Systems, due to an internal pump component from three specific lots. The root cause investigation of the issue is ongoing. The risk exists only when the pump is stopped, for example in a controller exchange when an attempt is made to restart the pump. A delay or failure to restart could occur at any time after a pump stop or after a pump has successfully restarted after a pump stop event. This issue does not impact the performance of a pump while it is running. Pumps in this subset have experienced a 5.2% rate of failing to initially start, restart or experiencing a delay to restart. Healthcare professionals are advised to remind their patients and staff to adhere to the Instructions for Use to avoid unnecessary pump stops and to follow the patient management recommendations regarding controller exchange in the letter, for the subset of devices that exhibit the higher rate of failure. 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.