FDA Device recall Z-1860-2021
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated wi…
- FDA Device
- Class I
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class I recall of Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated wi… by Medtronic Vascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1860-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-05-04 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Vascular |
| Distribution | CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI |
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.
Identifiers
| code_info | GTIN: 00673978284569, 20613994885306, 00673978284576, 00673978284620, 20613994885337,00673978284729, 20613994885399, 20…GTIN: 00673978284569, 20613994885306, 00673978284576, 00673978284620, 20613994885337,00673978284729, 20613994885399, 20613994994534. Serial Number/Lot Number GFRF0544 GFTJ1064 GFTJ2054 GFWD3486 GFAP4022 GFAP4023 GFAR1705 GFAS0270 GFAS0271 GFAU2099 GFAU2100 GFAV2023 GFAW0536 GFAX0346 GFAX0347 GFAX0348 GFAX0349 GFAY0671 GFAY0672 GFAZ0120 GFAZ0121 GFBN0459 GFBP1047 GFBP1048 GFBQ1629 GFBQ1630 GFBQ1631 GFBW0577 GFCV1818 GFCX1086 GFDP0187 GFWE3973 GFWE3974 GFWF3611 GFWG4429 GFWG4430 GFWG4432 GFWH2553 GFWI3563 GFWK0060 GFWK0061 GFWK0062 GFWL0066 GFWL2778 GFWL2780 GFXB0138 GFXB0141 GFXB3088 GFXB3089 GFXB3090 GFXC3702 GFXC3703 GFXD4073 GFXD4074 GFXF2023 GFXF2024 GFXF2025 GFXG1318 GFXG1320 GFXH2124 GFXH2125 GFXI1282 GFXI1445 GFXJ0688 GFXJ0689 GFYE0603 GFYF0667 GFYG1165 GFZA1155 GFZA1156 GFZB0256 GFZB0257 GFZC1428 GFZF0937 GFZH0811 GFZH0812 GFZJ1128 GFUG2639 GFTH1503 GFTJ0708 GFBY3756 GFXJ0691 GFRI1386 GFXC3695 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1860-2021%22
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