FDA Medical devices recall · November 20, 2024

The EVSRF catheter is a sterile, single-use disposable medical device for… recall

Read the official FDA notice ↗

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.

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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)

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.

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0371-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.