Voluntary recall of selected HeartWare® Controllers

HeartWare Inc. (‘HeartWare’) would like to inform healthcare professionals of a voluntary recall of selected HeartWare Ventricular Assist System Controllers. HeartWare is initiating this recall due to identified risks associated with electrostatic discharge (ESD). The affected Controllers are found to exhibit a higher susceptibility to ESD as compared to newer Controllers. An ESD event may cause or contribute to a pump stop requiring Controller exchange. Healthcare professionals are advised to identify patients with the affected Controllers, and review the applicable risks associated with a Controller exchange. If medically advisable, the affected primary controllers should be exchanged in a controlled setting under medical supervision. Healthcare professionals are advised to 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.