Medtronic’s decision to stop the distribution and sale of the Medtronic HVAD™ System

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of Medtronic's decision to stop the distribution and sale of the HeartWare™ Ventricular Assist Device (HVAD™) System due to a growing body of observational clinical comparisons demonstrating a higher frequency of neurological events and mortality with the HVAD™ System as compared to other commercially available left ventricular assist devices (LVADs). Medtronic had also received complaints involving delay or failure to restart the HVAD™ pump after it has stopped, but has not been able to pinpoint a root cause for each pump restart failure. Healthcare professionals are advised to immediately stop new implants of the Medtronic HVAD™ System. Prophylactic explant is not recommended for patients implanted with HVAD™ as the associated risks may outweigh the potential benefits. Healthcare professionals are advised to continue to follow best clinical practices and manage these patients according to the recommendations in the Instructions for Use. For patients in need of LVAD replacement, the use of alternative commercial LVADs (such as the Abbott HeartMate™ 3 LVAD) is recommended. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

11 Jun 2021

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.