Bard Peripheral Vascular recalls EVSRF catheters with internal wiring errors that cause overheating. Affected units have swapped red/yellow signal wires, risking burns and tissue damage during radiofrequency ablation procedures.
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.
Bard Peripheral Vascular is recalling EVSRF catheters that may have internal wiring errors. This error causes the catheter to overheat during radiofrequency ablation procedures, potentially causing burns or tissue damage. The recall affects specific model numbers and serial numbers.
The catheter's red and yellow signal wires were soldered on swapped ports. This error causes power to be applied through the proximal 3/4th of the heating coil, bypassing the thermocouple. The device then overheats beyond therapeutic levels while the console falsely indicates the temperature is still below the target.
Medical professionals using the EVSRF catheter for endovenous radiofrequency ablation procedures. Patients who have received the recalled catheter during treatment are at risk of burns or tissue damage.
Check for the following: Catalog Number VC-10A2.5-6F-100, VC-10A2.5-6F-60, or VC10A256F100. Also check the UDI codes and lot numbers listed in the recall notice.
Immediately stop using the EVSRF catheter if it is affected by the wiring error.
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure to thermally coagulate a refluxing vein to permanently eliminate it from blood circulation.
Check the catalog number (VC-10A2.5-6F-100, VC-10A2.5-6F-60, VC10A256F100, VC10A256F60, or VCOUS6F100, VCOUS6F60) and the UDI codes and lot numbers listed in the recall notice.
Immediately stop using it and contact Bard Peripheral Vascular for instructions on disposal or replacement.
We’ve drafted a message you can send Bard Peripheral Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0371-2025 — Bard Peripheral Vascular Bard Peripheral Vascular Hello, I own a Bard Peripheral Vascular that is covered by recall Z-0371-2025 from Bard Peripheral Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
