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Health Sciences Authority
Dear Healthcare Professional Letters

Hazard alert for HeartWare® Ventricular Assist Device System

Audiences

Healthcare professional

Product type

Medical devices

26 April 2018

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

HeartWare Inc. (HeartWare) would like to inform healthcare professionals of the introduction of an updated HeartWare® Ventricular Assist Device (HVAD) Controller (Controller 2.0) and the removal procedures for previous generation HVAD Controllers which are incompatible with Controller 2.0. This is to address the safety issues associated with the current Controllers as communicated in July 2015 and June 2016. While HeartWare recommends that all patients’ HVAD Controllers are to be exchanged, healthcare professionals are advised to weigh the benefits of the updated Controller against the risk of a controller exchange procedure. Healthcare professionals are also reminded to continue to reinforce safe use of the HAVD controller to their patients and staff, and to replace the HAVD Controllers and DC Adapters only after the trainings by HeartWare are completed. 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.

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