The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequen...
FDA Device Recall #Z-0371-2025 — Class II — September 4, 2024
Recall Summary
| Recall Number | Z-0371-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 4, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Peripheral Vascular Inc |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 222,373 catheters |
Product Description
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.
Reason for Recall
The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Australia, Singapore, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Slovenia Spain, Sweden, Switzerland, United Kingdom, United Arab Emirates, and South Africa.
Lot / Code Information
Catalog Number: VC-10A2.5-6F-100 UDI does: (01)00858254006015(17)241009(10)65497423 (01)00858254006015(17)241006(10)66030181 (01)00858254006015(17)241011(10)66599182 (01)00858254006015(17)241017(10)66634308 (01)00858254006015(17)241020(10)66784768 (01)00858254006015(17)241026(10)66793709 (01)00858254006015(17)241028(10)66793710 (01)00858254006015(17)241103(10)66897727 (01)00858254006015(17)241113(10)66947733 (01)00858254006015(17)241117(10)67054619 (01)00858254006015(17)241130(10)67308611 (01)00858254006015(17)250322(10)69548248 (01)00858254006015(17)250419(10)69548249 (01)00858254006015(17)250423(10)69548250 (01)00858254006015(17)250427(10)69567357 (01)00858254006015(17)250511(10)69567358 (01)00858254006015(17)250515(10)70322501 (01)00858254006015(17)250607(10)70523716 (01)00858254006015(17)250523(10)70597994 (01)00858254006015(17)250525(10)70751594 (01)00858254006015(17)250606(10)70791660 (01)00858254006015(17)250613(10)71054985 (01)00858254006015(17)250620(10)71197454 (01)00858254006015(17)250703(10)71197455 (01)00858254006015(17)250801(10)71197574 (01)00858254006015(17)250622(10)71319092 (01)00858254006015(17)250630(10)71361455 (01)00858254006015(17)250712(10)71589682 (01)00858254006015(17)250721(10)71780480 (01)00858254006015(17)250724(10)71780481 (01)00858254006015(17)250821(10)71974718 (01)00858254006015(17)250803(10)72167973 (01)00858254006015(17)250821(10)72216631 (01)00858254006015(17)250809(10)72216758 (01)00858254006015(17)250810(10)72282293 (01)00858254006015(17)250828(10)72440542 (01)00858254006015(17)250914(10)72491306 (01)00858254006015(17)250905(10)72609982 (01)00858254006015(17)250912(10)72735944 (01)00858254006015(17)250920(10)72845915 (01)00858254006015(17)250927(10)73024457 (01)00858254006015(17)250929(10)73184835 (01)00858254006015(17)251005(10)73218082 (01)00858254006015(17)251011(10)73319890 (01)00858254006015(17)251012(10)73424182 (01)00858254006015(17)251102(10)73441733 (01)00858254006015(17)251121(10)73808592 (01)00858254006015(17)251125(10)74103378 (01)00858254006015(17)251127(10)74171115 (01)00858254006015(17)251129(10)74219123 (01)00858254006015(17)260112(10)74355356 (01)00858254006015(17)241108(10)V67114001 (01)00858254006015(17)241108(10)V67114002 (01)00858254006015(17)241108(10)V67114003 Lot Numbers: 65497423 66030181 66599182 66634308 66784768 66793709 66793710 66897727 66947733 67054619 67308611 69548248 69548249 69548250 69567357 69567358 70322501 70523716 70597994 70751594 70791660 71054985 71197454 71197455 71197574 71319092 71361455 71589682 71780480 71780481 71974718 72167973 72216631 72216758 72282293 72440542 72491306 72609982 72735944 72845915 73024457 73184835 73218082 73319890 73424182 73441733 73808592 74103378 74171115 74219123 74355356 V67114001 V67114002 V67114003 Catalog Number: VC-10A2.5-6F-60 UDI codes: (01)00858254006008(17)241013(10)66186400 (01)00858254006008(17)241024(10)66793696 (01)00858254006008(17)241102(10)66793697 (01)00858254006008(17)241107(10)66793698 (01)00858254006008(17)241021(10)66802218 (01)00858254006008(17)241031(10)66863470 (01)00858254006008(17)241110(10)66981017 (01)00858254006008(17)241120(10)67017611 (01)00858254006008(17)241125(10)67105253 (01)00858254006008(17)241115(10)67190839 (01)00858254006008(17)241123(10)67241133 (01)00858254006008(17)241128(10)67429950 (01)00858254006008(17)241204(10)67429951 (01)00858254006008(17)241204(10)67429952 (01)00858254006008(17)250410(10)69548196 (01)00858254006008(17)250327(10)69548197 (01)00858254006008(17)250416(10)69548198 (01)00858254006008(17)250331(10)69659895 (01)00858254006008(17)250502(10)69659896 (01)00858254006008(17)250505(10)69748757 (01)00858254006008(17)250509(10)69928277 (01)00858254006008(17)250601(10)70414634 (01)00858254006008(17)250517(10)70487066 (01)00858254006008(17)250519(10)70634659 (01)00858254006008(17)250529(10)70673130 (01)00858254006008(17)250604(10)70868426 (01)00858254006008(17)250608(10)70933358 (01)00858254006008(17)250612(10)70994254 (01)00858254006008(17)250614(10)71075353 (01)00858254006008(17)250618(10)71197363 (01)00858254006008(17)250704(10)71197364 (01)00858254006008(17)250705(10)71197365 (01)00858254006008(17)250806(10)71197533 (01)00858254006008(17)250625(10)71278440 (01)00858254006008(17)250628(10)71278441 (01)00858254006008(17)250707(10)71609707 (01)00858254006008(17)250727(10)71629666 (01)00858254006008(17)250714(10)71650328 (01)00858254006008(17)250710(10)71650329 (01)00858254006008(17)250717(10)71818971 (01)00858254006008(17)250719(10)71818972 (01)00858254006008(17)250731(10)71913951 (01)00858254006008(17)250814(10)72151238 (01)00858254006008(17)250816(10)72216513 (01)00858254006008(17)250807(10)72248924 (01)00858254006008(17)250825(10)72405570 (01)00858254006008(17)250823(10)72475111 (01)00858254006008(17)250903(10)72524414 (01)00858254006008(17)250831(10)72576947 (01)00858254006008(17)250907(10)72640519 (01)00858254006008(17)250910(10)72768920 (01)00858254006008(17)250918(10)72812308 (01)00858254006008(17)250922(10)72978442 (01)00858254006008(17)250925(10)73048080 (01)00858254006008(17)250927(10)73141510 (01)00858254006008(17)251008(10)73184825 (01)00858254006008(17)251015(10)73441652 (01)00858254006008(17)251017(10)73493157 (01)00858254006008(17)251025(10)73542584 (01)00858254006008(17)251029(10)73656671 (01)00858254006008(17)251123(10)73656672 (01)00858254006008(17)251201(10)74137006 (01)00858254006008(17)251204(10)74137007 (01)00858254006008(17)251206(10)74288518 (01)00858254006008(17)260114(10)74355347 (01)00858254006008(17)260121(10)74989575 Lot Numbers: 66186400 66793696 66793697 66793698 66802218 66863470 66981017 67017611 67105253 67190839 67241133 67429950 67429951 67429952 69548196 69548197 69548198 69659895 69659896 69748757 69928277 70414634 70487066 70634659 70673130 70868426 70933358 70994254 71075353 71197363 71197364 71197365 71197533 71278440 71278441 71609707 71629666 71650328 71650329 71818971 71818972 71913951 72151238 72216513 72248924 72405570 72475111 72524414 72576947 72640519 72768920 72812308 72978442 73048080 73141510 73184825 73441652 73493157 73542584 73656671 73656672 74137006 74137007 74288518 74355347 74989575 Catalog Number: VC10A256F100 UDI codes: (01)00858254006015(17)260222(10)74959653 (01)00858254006015(17)260227(10)75563807 (01)00858254006015(17)260402(10)76413778 (01)00858254006015(17)260524(10)77536423 (01)00858254006015(17)260529(10)77750390 Lot Numbers: 74959653 75563807 76413778 77536423 77750390 Catalog Number: VC10A256F60 UDI codes: (01)00858254006008(17)260215(10)75087737 (01)00858254006008(17)260304(10)75439758 (01)00858254006008(17)260306(10)75784764 (01)00858254006008(17)260311(10)75828822 (01)00858254006008(17)260314(10)75940087 (01)00858254006008(17)260326(10)76272657 (01)00858254006008(17)260412(10)76413711 (01)00858254006008(17)260422(10)76960626 (01)00858254006008(17)260424(10)77048331 (01)00858254006008(17)260425(10)77093851 (01)00858254006008(17)260502(10)77115614 (01)00858254006008(17)260603(10)77272719 (01)00858254006008(17)260605(10)77948128 (01)00858254006008(17)260611(10)77984934 (01)00858254006008(17)260617(10)78094204 (01)00858254006008(17)260621(10)78220237 (01)00858254006008(17)260626(10)78295294 (01)00858254006008(17)260701(10)78387756 Lot Numbers: 75087737 75439758 75784764 75828822 75940087 76272657 76413711 76960626 77048331 77093851 77115614 77272719 77948128 77984934 78094204 78220237 78295294 78387756 Catalog Number: VCOUS6F100 UDI codes: (01)00858254006244(17)251005(10)73310842 (01)00858254006244(17)251009(10)73319925 (01)00858254006244(17)251214(10)73319926 (01)00858254006244(17)251023(10)73388088 (01)00858254006244(17)251109(10)73623196 (01)00858254006244(17)251112(10)73923359 (01)00858254006244(17)251114(10)73954408 (01)00858254006244(17)251116(10)73987507 (01)00858254006244(17)251214(10)74020834 (01)00858254006244(17)260107(10)74507761 (01)00858254006244(17)260110(10)74889457 (01)00858254006244(17)260116(10)74933204 (01)00858254006244(17)260124(10)75016007 (01)00858254006244(17)260130(10)75127795 (01)00858254006244(17)260204(10)75204432 (01)00858254006244(17)260206(10)75276852 (01)00858254006244(17)260214(10)75305699 (01)00858254006244(17)260404(10)76413837 (01)00858254006244(17)260406(10)76480490 (01)00858254006244(17)260506(10)76526332 (01)00858254006244(17)260507(10)77379776 (01)00858254006244(17)260507(10)77379777 Lot Numbers: 73310842 73319925 73319926 73388088 73623196 73923359 73954408 73987507 74020834 74507761 74889457 74933204 75016007 75127795 75204432 75276852 75305699 76413837 76480490 76526332 77379776 77379777 Catalog Number: VCOUS6F60 UDI codes: (01)00858254006251(17)251020(10)73319896 (01)00858254006251(17)251107(10)73573950 (01)00858254006251(17)251119(10)73890876 (01)00858254006251(17)251214(10)74070677 (01)00858254006251(17)260208(10)74507759 (01)00858254006251(17)260409(10)76413830 (01)00858254006251(17)260507(10)76593887 Lot Numbers: 73319896 73573950 73890876 74070677 74507759 76413830 76593887
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| Z-2638-2025 | Class II | Venclose digiRF Generators, Model VCRFG1, with ... | Aug 21, 2025 |
| Z-1244-2025 | Class I | Rotarex Atherectomy System and Instructions for... | Feb 5, 2025 |
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.