Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Angiographic Guidewire Component: Model Number: 107042 Recalled by Medtronic Vascular Due to The component part numbers intended for shipment to...

Date: May 4, 2021
Company: Medtronic Vascular
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Vascular directly.

Affected Products

Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.

Quantity: 54,997 units

Why Was This Recalled?

The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.

Where Was This Sold?

This product was distributed to 11 states: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI

Affected (11 states)Not affected

About Medtronic Vascular

Medtronic Vascular has 211 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report