AlboGraft polyester vascular graft 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

In June 2012 the MHRA lifted the prohibition on the sale of AlboGraft polyester vascular grafts and withdrew MDA/2012/018.However, the advice given in MDA/2012/010MDA/2012/010 – that these grafts should be leak tested prior to use – continues to apply until the end of December 2012.In April 2012 the MHRA issued MDA/2012/018 informing users of the Prohibition Notice preventing the manufacturer from selling the AlboGraft in the UK. The MHRA has since carried out a detailed audit of the graft manufacturing facility.  We were provided with evidence of a number of ongoing changes that the manufacturer was making to the processes to improve control of manufacturing. As a consequence the MHRA has now lifted the Prohibition Notice and permitted sales of the AlboGraft in the UK. Until the end of 2012, however, we are continuing to advise clinicians to undertake the leak test described in MDA/2012/010. This is to ensure that products manufactured before and during these improvements do not show any of the previous problems. The MHRA will issue more advice if further significant adverse incidents are reported.