Voluntary recall of specific lots of Lotus™ Valve System

Boston Scientific Asia Pacific Pte Ltd  would like to inform healthcare professionals of the recall of certain lots of Boston Scientific Lotus™ Valve System due to the potential for the release mandrel to break. The affected lots were manufactured prior to a component related change made in March 2016. The most common outcome resulting from a broken release mandrel is procedure prolongation due to the need to remove and replace the device. The most severe outcome was catastrophic vessel trauma associated with patient death, which was reported in three cases. Healthcare professionals are advised to return the affected devices to Boston Scientific. There is no impact to previously implanted valves as the issue involves the delivery system only. 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). 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.