Incorrect MRI information on Instructions for use (IFU) of Cordis S.M.A.R.T. and PRECISE Stents

Cardinal Health Singapore 225 Pte. Ltd. would like to inform healthcare professionals that the Instructions for use (IFU) of Cordis S.M.A.R.T. and PRECISE stents have incorrectly stated the products as "MRI safe" when the correct classification is "MRI Conditional". Operation of MRI outside the required MRI conditions may result in bleeding, thrombosis, migration, perforation, restenosis, burns, bilious leak, biliary peritonitis, or inappropriate diagnoses and/or therapies due to image artifacts. Cordis has not received any reports of patient harm or injury due to this issue. The IFU and Implant Cards for S.M.A.R.T. and PRECISE stents will be updated with the relevant MRI safety information. Healthcare professionals are advised to ensure that MR imaging is only carried out within parameters specified for each device type in accordance with the updated MRI safety conditions specified in the letter. 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.