Voluntary removal of Eluvia™ 150mm and Innova™ 180mm & 200mm Stent Systems due to elevated complaint rates for partial stent deployment

Boston Scientific Asia Pacific Pte Ltd would like to inform healthcare professionals of the voluntary removal of the 150mm Eluvia™Drug-Eluting Vascular Stent System and the 180mm and 200mm Innova™ Self-Expanding Stent System due to elevated complaint rates for partial stent deployment. This issue does not affect stents already implanted in patients. Healthcare professionals are advised to discontinue use of the affected device and return the unused affected devices. Stents of shorter lengths models from the Eluvia™ or Innova™ stent system can be combined to replace the affected models. Please refer to the letter for details. 

 
 
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on 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://www.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 'Restricted Content' and log in via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’.

Step 4: Click on the Drug Alert tab to view the DHCPLs.