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Health Sciences Authority
Dear Healthcare Professional Letters

HeartWare™ Ventricular Assist Device (HVAD™) System - Hardened Driveline Cover Hindering Driveline Disconnection

Audiences

Healthcare professional

Industry member

Product type

Medical devices

5 December 2022

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 that the driveline cover of the HeartWare™ Ventricular Assist Device (HVAD™) System may harden over time due to plasticizer loss and cause difficulty or inability to slide the cover back to access the driveline to the controller connector. This issue may cause access to the driveline connector to be delayed, potentially resulting in patient harm from a prolonged pump stop if an urgent driveline connection or controller issue needs to be addressed. Healthcare professionals are advised to contact Medtronic International Limited for assessment and/or servicing in the event of any damage or difficulty observed with a hardened driveline cover. 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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