A field safetynotice has been issued to correct a labelling issue by Cordis for self-expanding stents under MRI, specifically for SMART and PRECISE.
MRI radiographers and healthcare professionals in the UK have been asked to ‘read and understand the updated compatibility information’ and share with relevant people in their organisations.
The document states “Cordis became aware that the Instructions for use (IFU) for the SMART and PRECISE stents do not have correct language around the usage of the product with MRIs.”
Specifically, the IFU for multiple implantable products have ‘MRI safe’ wording under the MRI compatibility information, but to meet regulatory standards this should be labelled instead as ‘MRI conditional’.
There are various risks attached if MRI is operated outside the required conditions for these stents including bleeding, thrombosis and migration.
The alert, which comes from the Medicines and Healthcare products Regulatory Agency, also asks all organisations in the UK to return the acknowledgement form by 12 March, ‘even if you don’t have affected devices left in stock.’
Suspected or adverse events involving these devices should be reported through local reporting systems and your national incident reporting authority.