Product Liability: the voluntary recall of some Medtronic guidewires has now been classified class I recall by the US FDA
Some defectives guidewires manufactured by Medtronic can cause serious injury or death. The voluntary recall initiated by Medtronic in October was recently classified as a Class I recall by the US FDA.
Guidewires are inserted in arteries to guide and place stents. Those being recalled have a coating that can break off and block a blood vessel.
Medtronic initiated the recall after four problems were reported including one patient who suffered cardiac arrest but was resuscitated according to WebMD