Voluntary recall of specific sizes of Zenith Alpha™ Thoracic Endovascular Graft due to removal of indication for use in blunt thoracic aortic injury

Cook South East Asia Pte Ltd would like to inform healthcare professionals of a voluntary recall of specific sizes of the Zenith Alpha™ Thoracic Endovascular Graft from the market that would likely be used only for blunt thoracic aortic injury (BTAI). This is due to the voluntary removal of the indication for use in BTAI in the Instructions for Use (IFU) following additional complaints of graft thrombosis/occlusion when the product was used to treat BTAI. Healthcare professionals are advised to follow up with patients already treated with the product for BTAI according to current IFU. Please refer to the letter for more 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.