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Health Sciences Authority
Dear Healthcare Professional Letters

Physiological or procedural elements likely to increase the risk of thrombosis associated with the Vascutek Terumo Thoraflex™ Hybrid

Audiences

Healthcare professional

Industry member

Product type

Medical devices

12 December 2024

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 Terumo Asia Holdings Pte. Ltd. to inform healthcare professionals about the latest Vascutek Terumo ThoraflexTM Hybrid Instructions For Use (IFU) which has been updated to align with EU MDR certification requirements. Updates to the IFU include further information on distal device oversizing and sealing, as well as physiological and operative risk factors which are likely to increase the risk of thrombosis associated with endo prostheses. Healthcare professionals are advised to refer to the updated IFU for instructions on creating a safe distal seal for the implant and reducing the potential to generate thrombus events. 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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