Lower risk Medical device recall · FDA · Published August 21, 2025

Bard Venclose digiRF Generators with Software 3.35 May Cause False Failures

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2638-2025Medical device Bard ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1, 850 W. Rio Salado Prkwy. · Tempe, AZ 85281-2438

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/51563-bard-venclose-digirf-generators-with-software-3-35-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/51563-bard-venclose-digirf-generators-with-software-3-35-may-cause · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2638-2025

Cite this page

“Bard Venclose digiRF Generators with Software 3.35 May Cause False Failures.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51563-bard-venclose-digirf-generators-with-software-3-35-may-cause. Based on FDA recall #Z-2638-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2638-2025%22&limit=1).

The FDA announced on August 21, 2025, that Bard Peripheral Vascular Inc is recalling Venclose digiRF Generators, Model VCRFG1, with software version 3.35. The device may incorrectly flag functional catheters as defective due to temperature-dependent verification errors.

How to tell if you have it

Brand: Bard
Product: Venclose digiRF Generator
Model: VCRFG1
Software Version: 3.35
Quantity: 1,725 units

The hazard

The generator's software generates false positive failures because of temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at a steady state. When this occurs, the generator displays a Red X indicator without error codes, disabling catheter functionality.

Context

GovInfoNow's records show Bard Peripheral Vascular Inc has issued 40 other recalls since September 22, 2017. Recent recalls include the EnCor EnCompass Breast Biopsy and Tissue Removal System Console on August 20, 2026, and Broviac Cutdown Trays with SureCuff Cuff on December 12, 2025. Other recent recalls of similar products include Bard PowerPICC SOLO HF Catheter Recall (May 21, 2026), Bard Power-Trialysis Dialysis Catheters Recall (May 21, 2026), and Bard PowerMidline Catheter Recall (May 21, 2026).

How to tell if you have this one

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.

Brand
Bard
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Look for the software version on your Venclose digiRF Generator; if it's 3.35, it's affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 43 states.

FDA distribution: “Worldwide - US Nationwide distribution including in the states of NJ, NY, FL, LA, VA, CA, TX, NV, PA, NE, TN, IL, AZ, SC, AK, GA, CO, HI, OH, NC, WI, WV, MD, MO, AL, OK, MS, PR, KS, UT, CT, IA, MI, IN, MA, KY, WA, MT, MN, SD, ME, DE, NM,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 48 days after the firm started it.

Aug 21, 2025Firm started the recall
Sep 26, 2025FDA classified it Class II
Oct 8, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using my generator?

No, you don't need to stop using it immediately. The issue only affects the software check process, not the device's overall function.

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Link to this recall

<a href="https://govinfonow.com/recall/51563-bard-venclose-digirf-generators-with-software-3-35-may-cause">Bard Venclose digiRF Generators with Software 3.35 May Cause False Failures (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2638-2025 (August 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2638-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.