Recall Z-1860-2021— Medtronic Vascular
Class I · Terminated
Class I FDA medical device recall by Medtronic Vascular, initiated 2021-05-04, terminated 2023-01-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Medtronic Vascular
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-05-04
- Terminated
- 2023-01-05
- Firm location
- Danvers, MA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.