| | Class 2 Device Recall Venclose RF Ablation Catheter (VC10A256F60, VC10A256F100, VCOUS6F60, and VCOUS6F100) |  |
| Date Initiated by Firm | September 04, 2024 |
|---|
| Date Posted | November 13, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0371-2025 |
|---|
| Recall Event ID |
95408 |
| 510(K)Number | K160754 |
|---|
| Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
|
| Product | 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. |
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| 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 |
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438
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| For Additional Information Contact | Shanna Perrone
267-810-4653 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Employee error |
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| Action | On 10/16/2024, the firm sent an "URGENT: Medical Device Product Removal" letter via FedEx or email to customers informing them that the Venclose RF Ablation Catheters may have been manufactured with internal wiring errors that could cause inaccurate temperature detection resulting in devices reaching temperatures higher than intended, while the user receives incorrect warnings that the catheter has not reached temperature.
Customers are instructed to:
1. Please cease use of product listed in this letter, and immediately quarantine all affected product remaining in their possession.
2. The Venclose" RF Generator, which is used in conjunction with the Venclose" RF Ablation Catheters, contains software that requires an upgrade to be performed prior to using the impacted Venclose" RF Ablation Catheters. Venclose" RF Ablation Catheters that are not listed as impacted as per attachment 1, can continue to be used.
3. The affected devices should not be used until after the Venclose" RF Generator software has been updated by a BD representative.
4. A BD Representative will contact your facility in order to arrange the upgrade to your facility s Venclose" RF Generator software. The upgrade will be performed by a BD Representative upon completion of the Customer Response Form.
5. After the confirmed Venclose" RF Generator software has been updated, the products listed in this letter can be used as normal.
6. Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, please ensure that these entities are contacted and informed of the recall.
7. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not you have any of the impacted product so that BD may acknowledge your receipt of this notification. Indicate on the response form that the impacted product has been was quarantined by |
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| Quantity in Commerce | 222,373 catheters |
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| Distribution | 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.
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| Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = GEI
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