Voluntary recall of Misago® Self-Expanding Stent System

Terumo Singapore Pte Ltd would like to inform healthcare professionals of the voluntary recall of Misago® Self-Expanding Stent System. An investigation has determined that compression forces applied to the stent during mounting to delivery catheter may cause minor deformation and/or overlapping of stent-struts. This may result in reduced diameter at the ends of the stent during deployment or deformation of stent shape. Terumo determined that these nonconformities would not affect safety or effectiveness of the product. However, a recall is initiated as it cannot be confirmed if all stents released onto the market meet all defined specifications. Healthcare Professionals are advised to return all unused affected devices to Terumo. 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.