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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Industry member

Product type

Medical devices

4 June 2021

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

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.

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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