Medical device manufacturer, Vascutek Ltd, a Terumo Company, has issued a field safety notice concerning Anaconda ONE-LOK Bifurcate Body and Anaconda Bifurcate Body. The affected catalogue numbers are as follows:
Vascutek Ltd has received three complaints (with an occurrence rate of 0.1%) where the release wire of an Anaconda Body delivery system has fractured following stent deployment. Two of these three incidents resulted in conversion to open repair.
The voluntary recall addresses potential risks associated with the wire fracturing and the possibility of conversion to open repair.
According to the manufacturer, this is a potential failure mode of to delivery system and does not affect the safety or efficacy of the implantable stent. Previously implanted stents are not affected by this voluntary recall.
Furthermore, according to the manufacturer, there is no suggestion that patients already implanted with Anaconda One- Lok Bifurcate Body or Anaconda Bifuracte Body are exposted to any raised level of risk.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 October 2013