Potential malfunction of the HeartWare™ Ventricular Assist Device (HVAD™) System

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of potential malfunction of the HeartWare™ Ventricular Assist Device (HVAD™) System, where patients with affected devices may present with signs and symptoms that resemble pump thrombosis. Ongoing investigation suggested that reported cases of device malfunction was caused by a weld defect that allowed moisture into the centre post and corroded the magnets that kept the impeller rotating concentrically. An active investigation is in progress to identify which HVAD™ pumps may be affected. Routine prophylactic explantation of the HVAD™ device is not recommended, as risks associated with explantation may outweigh the potential benefits. Healthcare professionals are advised to make the decision regarding explant and exchange of the HVAD™ pump on a case-by-case basis, considering the patient’s clinical condition and surgical risks. For patients presenting with any of the signs and symptoms that resemble pump thrombosis, healthcare professionals are advised to consider whether the clinical presentation could be due to a pump thrombus and treat accordingly. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

5 May 2022

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.