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.

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.