ClearanceBrief
Recall Z-0371-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories

Bard Peripheral Vascular Inc

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 energi

DateNov 13, 2024 (initiated Sep 4, 2024)
StatusOpen, Classified
ReasonThe 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 t
Root causeEmployee error
ActionOn 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 Ven
Quantity222,373 catheters
DistributionWorldwide - 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, Sing
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
Venclose, Inc., Sep 9, 2016