FDA Device recall Z-0371-2025

The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a reflux…

• FDA Device
• Class II
• ongoing
• Published 2024-11-20

On 2024-11-20 the FDA classified a Class II recall of The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a reflux… by Bard Peripheral Vascular, citing 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….

Read the official FDA Device 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.

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0371-2025%22

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