Recall of VICI and VICI RDS™ Venous Stent Systems due to reports of stent migration after implantation

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to inform healthcare professionals of a recall of all lots/batches of the VICI and VICI RDS™ Venous Stent Systems in response to reports of stent migration after implantation. Some stent migrations have led to the need for endovascular intervention to secure or retrieve the stent; in more severe cases, the stent embolized to the heart and required surgeries. Healthcare professionals are advised to cease further distribution or use of the affected products. For patients who have had VICI venous stents placed, healthcare professionals are recommended to continue regular or routine check-ups and follow-up care. No additional action is recommended if the patients are not having any complications or symptoms. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

23 Apr 2021

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). HPP is 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: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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

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