Medtronic Vascular recalls Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire comp…

Recall date

May 4, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1860-2021

FDA classification

Class I

Brand / firm

Medtronic Vascular

Sold / distributed

US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.