Bard recalls Venclose digiRF Generators (Model VCRFG1) with software 3.35 that may falsely flag Venclose EVSRF Ablation Catheters as defective due to temperature issues during verification.
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.
Bard is recalling Venclose digiRF Generators with software version 3.35 because this version incorrectly flags properly working catheters as defective due to temperature variations. This could lead to unnecessary procedure cancellations or delays if the generator stops functioning before the procedure starts.
The software version 3.35 performs a temperature check when connecting catheters. If the catheter isn't at a steady temperature, the software falsely flags it as defective, showing a red X without error codes. This can stop the procedure before it starts.
Users of Venclose digiRF Generators (Model VCRFG1) with software 3.35 are affected. Patients undergoing vein procedures with these devices may face unnecessary delays or cancellations if the generator incorrectly flags catheters as defective.
Check if your Venclose digiRF Generator has software version 3.35. The device model is VCRFG1, and it was sold with the Venclose EVSRF Ablation Catheters for vein procedures.
Look for the software version on your Venclose digiRF Generator; if it's 3.35, it's affected.
Software version 3.35 falsely flags catheters as defective when they're not properly heated, leading to unnecessary procedure stops.
No, you don't need to stop using it immediately. The issue only affects the software check process, not the device's overall function.
The official recall does not provide a fix; you may need to contact Bard for further instructions.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-2638-2025 — Bard Bard Hello, I own a Bard that is covered by recall Z-2638-2025 from Bard. 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.
