FDA Class I Recall: Angiographic Guidewire Component by Medtronic Vascular

July 6, 2021

Medtronic Vascular is recalling the Angiographic Guidewire Component because devices were not sterilized before being shipped directly to hospitals, released the U.S. Food and Drug Administration (FDA).

If patients are exposed to the non-sterile device, serious adverse events could occur, such as infection, sepsis, and death. There have been two complaints, and no reported injuries or deaths related to this issue. However, there is potential for underreporting as physicians may not have been aware that devices were non-sterile. 

Medtronic Vascular’s Angiographic Guidewire Component is a guidewire used during angiography or other interventional procedures to help place catheters into the vasculature. 

On May 4th, 2021, Medtronic Vascular sent an Urgent Medical Device Recall letter to affected customers. The letter provided the following instructions:

  • Identify and quarantine all unused affected Angiographic Guidewire components of the Urgent Medical Device Recall letter and the enclosed Customer Detail Report. 
  • Return or exchange all unused affected components in your inventory to Medtronic.

FDA has the recall.