The EVSRF catheter is a sterile — Class II medical device recall Z-0371-2025
Ongoing recall by Bard Peripheral Vascular Inc, reported 2024-11-20, distributed nationwide. The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow
| Recall number | Z-0371-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2024-09-04 |
| Classified | 2024-11-13 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CZ, DE, DK, ES, FR, GB, GR, IE, IT, PL, SE, SG, SI, ZA |
| Quantity | 222,373 catheters |
| UPC / GTIN / UDI-DI | 00858254006008, 00858254006015, 00858254006244, 00858254006251 |
| Lot numbers | 65497423, 66030181, 66186400, 66599182, 66634308, 66784768, 66793696, 66793697, 66793698, 66793709, 66793710, 66802218, 66863470, 66897727, 66947733, 66981017, 67017611, 67054619, 67105253, 67190839, 67241133, 67308611, 67429950, 67429951, 67429952, 69548196, 69548197, 69548198, 69548248, 69548249, 69548250, 69567357, 69567358, 69659895, 69659896, 69748757, 69928277, 70322501, 70414634, 70487066 and 132 more |
| Model numbers | VC-10A2.5-6F-100, VC-10A2.5-6F-60, VC10A256F100, VC10A256F60, VCOUS6F100, VCOUS6F60 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0371-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.