UK MHRA has issued a field safety notice pertaining to Vascutek’s Anaconda and Anaconda ONE-LOK™ Stent Graft Systems.
The Field Safety Notice can be found here.
In it the company provides details of reported cases in which “under exceptional circumstances an additional procedure may be required to remove the bifurcate body delivery system.”
The Notice is issued as guidance to increase clinician awareness and is not requiring of a product recall. Details of procedures to ensure the safe removal of the delivery system are provided.