Recall of HeartWare™ Ventricular Assist Device (HVAD™) System and other components

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited, as a follow up to their earlier communication in June 2021, to update healthcare professionals of the recall of the Medtronic HeartWare™ Ventricular Assist Device (HVAD™) System and other components. This follows the earlier discontinuation of distribution and sale of the HVAD™ System due to a growing body of observational clinical comparisons demonstrating a higher frequency of neurological events and mortality with it as compared to other commercially available left ventricular assist devices. Healthcare professionals are advised to return unused HVAD™ Pump Implant Kits and accessories, HVAD™ Pump Outflow Graft and Driveline Extension Cable to Medtronic. As prophylactic explant is not recommended for patients implanted with HVAD™ in view that the associated risks may outweigh the potential benefits, return of peripherals or HVAD™ Surgical Tools needed to manage patients currently on support is also not recommended. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

15 Jul 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.