Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators with software version 3.35. The recall centers on a catheter verification feature that can produce false positives and disable compatible EVSRF catheters. The worldwide distribution includes the United States. Patients and healthcare providers should stop using the device and await further instructions from the manufacturer.
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Bard Peripheral Vascular Inc or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Venclose digiRF Generator is a multi-voltage RF energy delivery system used with Venclose EVSRF Ablation Catheters for temperature-controlled vein ablation.
Software 3.35 verification may falsely flag working catheters as defective, disabling use before procedures begin.
This recall is not described as part of a broader industry pattern.
High hazard potential due to device functioning being disabled pre-procedure, requiring clinical oversight and potential schedule disruption.
Manufacturers' recall notice and FDA enforcement page; serial numbers on device label
Remediation timeline not specified; expect facility-level guidance and replacement options
Retain recall notice, device labels, UDI-DI, and correspondence with vendor
Model VCRFG1 with software 3.35. Distributor worldwide; US distribution in multiple states listed. 1,725 units recalled.
No specific injuries or patient harm data are provided in the recall notice. This entry notes a high-hazard warning but does not report injuries.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.
Mazda North American Operations recalls 2025 Mazda CX-70 plug-in hybrids as software issues in the inverter may cause the malfunction indicator lights to illuminate and a loss of drive power in EV mode. Dealers will update inverter software at no cost. Letters were mailed December 19, 2024.
Mazda North American Operations recalls certain 2024-2025 CX-90 and 2025 CX-70 vehicles with a Dash ESU due to startup function failures. Software reprogramming will remedy the issue at no charge. Owner notices were mailed December 18, 2024. Contact Mazda at 1-800-222-5500 Option 6. NHTSA ID 24V814000.
Subaru recalls 2025 Forester vehicles due to potentially loose child seat anchor bolts. Dealers will inspect and tighten bolts at no charge. Owner letters are expected August 15, 2025. Contact Subaru at 1-844-373-6614. Recall number WRC-25.
Nissan recalls 2025 Pathfinder, Murano and INFINITI QX60 for front brake caliper weakness that could fail. Dealers will inspect and replace calipers as needed, free of charge. Letters sent May 9, 2025. Contact Nissan or INFINITI for remedies.
Mazda North American Operations is recalling 2025 CX-50 Hybrid and CX-50 SUVs sold through Mazda dealers. Incorrectly configured restraint-control software may cause the air bag to deploy improperly. Owner notification letters are expected to be mailed August 17, 2025.
Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.
BMW recalls 2025-2026 X1 and X2 models plus MINI Cooper and Countryman variants for front seat belt retractors with damaged torsion bars. The defect may fail to restrain occupants in a crash. Dealers will replace both front retractors at no cost. Owner letters begin November 7, 2025. VIN lookup will be available on NHTSA.gov the same day.