Angiographic Guidewire Component: Model Number: 107042 — Class I medical device recall Z-1860-2021
Terminated recall by Medtronic Vascular, reported 2021-06-23, distributed in CA, KY, LA, MI, NE, NY, OH, OK…. The component part numbers intended for shipment to a third-party, where they are further processed into kits
| Recall number | Z-1860-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Danvers, MA, United States |
| Recall initiated | 2021-05-04 |
| Classified | 2021-06-16 |
| Reported by FDA | 2021-06-23 |
| Terminated | 2023-01-05 |
| Distributed | CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI |
| Countries outside the US | AU |
| Quantity | 54,997 units |
| UPC / GTIN / UDI-DI | 00673978284569, 00673978284576, 00673978284620, 00673978284729, 20613994885306, 20613994885337, 20613994885399, 20613994994534 |
| Lot numbers | GFAN0034, GFAN3402, GFAP4022, GFAP4023, GFAQ4326, GFAR1705, GFAS0270, GFAS0271, GFAS1779, GFAT2205, GFAU2099, GFAU2100, GFAU2102, GFAV2023, GFAV2025, GFAW0536, GFAW0540, GFAX0346, GFAX0347, GFAX0348, GFAX0349, GFAX0351, GFAY0671, GFAY0672, GFAY2480, GFAZ0120, GFAZ0121, GFAZ1728, GFBN0459, GFBN0463, GFBP1047, GFBP1048, GFBP1051, GFBP2548, GFBQ1629, GFBQ1630, GFBQ1631, GFBQ2337, GFBS2989, GFBT1262 and 119 more |
| Model numbers | 107042, 107044, 107447, 110003, 110004 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1860-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.