Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The a...
FDA Device Recall #Z-1860-2021 — Class I — May 4, 2021
Recall Summary
| Recall Number | Z-1860-2021 |
| Classification | Class I — Serious risk |
| Date Initiated | May 4, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Vascular |
| Location | Danvers, MA |
| Product Type | Devices |
| Quantity | 54,997 units |
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.
Distribution Pattern
US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia
Lot / 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
Other Recalls from Medtronic Vascular
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1245-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cmJL 3... | Jan 15, 2021 |
| Z-1247-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100cm EBU ... | Jan 15, 2021 |
| Z-1246-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cm JR... | Jan 15, 2021 |
| Z-1248-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cm EBU... | Jan 15, 2021 |
| Z-0087-2021 | Class I | Rashkind Balloon Septostomy Catheter, 6F, Reces... | Aug 25, 2020 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.