Class 1 Device Recall Angiographic Guidewire Component

• Date Initiated by Firm: May 04, 2021
• Date Posted: June 16, 2021
• Recall Status: Terminated on January 05, 2023
• Recall Number: Z-1860-2021
• Recall Event ID: 87952
• Product Classification: Guidewire, catheter, reprocessed - Product Code NKQ
• 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.
• Code Information: 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 GFXI1280 GFYA2177 GFYK1425 GFYK1426 GFYL2107 GFZA1161 GFZA1162 GFZB1164 GFZB1165 GFZB1166 GFZC0833 GFZC0834 GFZC0835 GFAN0034 GFAN3402 GFAQ4326 GFAS1779 GFAT2205 GFAU2102 GFAV2025 GFAW0540 GFAX0351 GFAY2480 GFAZ1728 GFBN0463 GFBP1051 GFBP2548 GFBQ2337 GFBS2989 GFBT1262 GFBU1912 GFBU1913 GFBV2111 GFBW0580 GFBX2576 GFBX2578 GFBY0801 GFCT1918 GFCU1707 GFCV3653 GFCW0885 GFCX3692 GFCY3186 GFCZ1176 GFDP1294 GFDQ1045 GFDR0722 GFDT3017 GFDT3533 GFDV0352 GFDV3567 GFDV3568 GFDW2107 GFDW2108 GFDX2649 GFDY2057 GFER1570 GFEV0322 GFEV0323 GFEV0325 GFYG1612 GFYI0525 GFYI0722 GFYJ0508 GFYJ2628 GFYK1607 GFYL2108 GFZA1163 GFZC1455 GFZF0944 GFZG0922 GFZH1464 GFZJ1140 GFZK1538 GFZL0749
• Recalling Firm/ Manufacturer: Medtronic Vascular; 35-37A Cherry Hill Drive; Danvers MA 01923-2565
• For Additional Information Contact: Medtronic Customer Service; 800-716-6700
• Manufacturer 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.
• FDA Determined 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 Angiographic Guidewire components. As a result, Medtronic requests that you immediately take the following actions: -Identify and quarantine all unused affected components identified in the customer letter. -Utilize standard hospital practice and policies to notify patients who were treated with the recalled components. -Return/Exchange all unused affected components in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-716-6700 to initiate a component return/exchange. Your local Medtronic Representative can assist you in the return of this component. Please refer to Table 2 for applicable part numbers to facilitate reordering. -Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. If you have any questions regarding this communication, please contact your Medtronic Field Representative or call:763-526 -8583 or email: rs.cvgrecalls@medtronic.com.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.