Medtronic Vascular Recalls Nonsterile Angiographic Guidewire Component

Medtronic Vascular is recalling an angiographic guidewire component because the devices were not sterilized before being shipped to hospitals.

Almost 55,000 of the devices distributed between Nov. 23, 2007, and March 29, 2021, are being recalled. The component is used during angiography and other interventional procedures to help place catheters into the vasculature.

The FDA has deemed this a Class I recall — the most serious type of recall — in that use of the devices could cause serious injury or death.