This is a very interesting post. I wonder that what might be the cause for the device failure. Because the device failure is after the market approval which means, initially there was no risk because of using this product. So it means that some change in the material of the device or something would have called this issue. On reading this post I remember a food product which got banned due to the trace of lead content elevation which would have led to severe health issues. So finally it was found that the source of water from which they were manufacturing turned to have higher lead levels which is the major reason for this issue. So this even created an awareness even the source of the element should be taken into consideration. So there may be any changes due to the source of the elements also.