Voluntary recall of selected lots of Cordis PRECISE® PRO RX Nitinol Stent System (Carotid)

Johnson & Johnson Pte Ltd has issued a Dear Healthcare Professional Letter to inform healthcare professionals of the voluntary recall of 179 lots of Cordis PRECISE® PRO RX Nitinol Stent System (Carotid) (“PRECISE® PRO Carotid Stent”). These 179 lots (manufactured between April 27, 2015 and November 22, 2015) were reported to have an increased frequency of users reporting difficulty with stent deployment and/or separation of the bond between sections of the device outer member.  The recall is for deployment issues and does not affect PRECISE® PRO stents successfully deployed. To date, no patient injuries have been reported in relation to this issue. Healthcare professionals are advised to identify and return all affected products to Johnson & Johnson Pte Ltd. 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.