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Medtronic Vascular recalls Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire c
Recalled June 23, 2021 · FDA recall Z-1860-2021 · Medtronic Vascular
Hazard
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. · FDA Class I
Units
54,997 units
Sold at
US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia
Description
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.
Product
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.
Manufacturer(s)
Medtronic Vascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →