Reported Nov 20, 2024 · Ongoing
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a…
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
- 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.
- Lot codes and dates
- Catalog NumberVC-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
654974236603018166599182666343086678476866793709667937106689772766947733670546196730861169548248695482496954825069567357695673587032250170523716705979947075159470791660710549857119745471197455711975747131909271361455715896827178048071780481719747187216797372216631722167587228229372440542724913067260998272735944728459157302445773184835732180827331989073424182734417337380859274103378741711157421912374355356V67114001
- V67114002 V67114003 Catalog NumberVC-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
66 of 66 codes
661864006679369666793697667936986680221866863470669810176701761167105253671908396724113367429950674299516742995269548196695481976954819869659895696598966974875769928277704146347048706670634659706731307086842670933358709942547107535371197363711973647119736571197533712784407127844171609707716296667165032871650329718189717181897271913951721512387221651372248924724055707247511172524414725769477264051972768920728123087297844273048080731415107318482573441652734931577354258473656671
- Catalog NumberVC10A256F100
- 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 Numbers74959653 75563807 76413778 77536423 77750390
- Catalog NumberVC10A256F60
- 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
750877377543975875784764758288227594008776272657764137117696062677048331770938517711561477272719779481287798493478094204782202377829529478387756
- Catalog NumberVCOUS6F100
- 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
73310842733199257331992673388088736231967392335973954408739875077402083474507761748894577493320475016007751277957520443275276852753056997641383776480490765263327737977677379777
- Catalog NumberVCOUS6F60
- 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 Numbers73319896 73573950 73890876 74070677 74507759 76413830 76593887
- Amount recalled
- 222,373 catheters
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Bard Peripheral Vascular Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.