Recall Z-1860-2021 ยท NKQ Guidewire, Catheter, Reprocessed
Medtronic Vascular
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.
| Date | Jun 16, 2021 (initiated May 4, 2021) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | In May, 2021, Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" notice to customers via letter notifying them Medtronic is voluntarily recalling certain lots of Angiographic Guidewire components. In June 2021, Medtronic issued AMENDED URGENT MEDICAL DEVICE RECALL notices to customers. On The component part numbers associated with this recall are intended for shipment to a third-party, where they are further processed into kits and sterilized, but were instead shipped directly to customers. Actions: Medtronic records indicate that your facility has received one or more of the affected A |
| Quantity | 54,997 units |
| Distribution | US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.