July 6, 2021

FDA: Class I recall of Medtronic angiographic guidewire

Editor's Note

The Food and Drug Administration (FDA) on July 2 identified the recall by Medtronic Vascular of its angiographic guidewire component as Class I, the most serious.

The recall was initiated because the devices were not sterilized before being shipped to hospitals.

The guidewire is used during angiography or other interventional procedures to help place catheters into the vasculature.

There have been 2 complaints and no reported injuries or deaths. Distribution dates were November 23, 2007, to March 29, 2021.

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