FDA MedWatch – Angiographic Guidewire Component by Medtronic Vascular:

TOPIC: Angiographic Guidewire Component by Medtronic Vascular: Class I Recall – Due to Being Non-sterile

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: Medtronic Vascular is recalling the Angiographic Guidewire Component because devices were not sterilized before being shipped directly to hospitals. 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.

For more information about this recall, click on the red button “Read Recall” below.

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

RECOMMENDATIONS: 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.
  • Contact Medtronic Customer Service to initiate a component return/exchange. Your local Medtronic Representative can assist you in the return of this component.
  • Refer to the Urgent Medical Device Recall letter for applicable part numbers to facilitate reordering.
• Complete the enclosed Customer Confirmation Form and email it.
  • Continue to monitor these patients in accordance with your medical facilities standard care protocols.
• Utilize standard hospital practice and policies to notify patients who were treated with the recalled components.
• Share the notice with all those who need to be aware within your organization and with any organization where the potentially affected devices have been transferred.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.