Quick Facts at a Glance
- Recall Date
- August 21, 2025
- Hazard Level
- HIGH
- Brand
- Bard Peripheral Vascular
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Bard Peripheral Vascular
- Product type
- RF Generator
- Model numbers
- UDI-DI: 00858254006022. Generator Software Version 3.35
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 21, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
Venclose digiRF Generator is a multi-voltage RF energy delivery system used with Venclose EVSRF Ablation Catheters for temperature-controlled vein ablation.
Why This Is Dangerous
Software 3.35 verification may falsely flag working catheters as defective, disabling use before procedures begin.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
High hazard potential due to device functioning being disabled pre-procedure, requiring clinical oversight and potential schedule disruption.
Practical Guidance
How to identify if yours is affected
- Check model number VCRFG1 and software version 3.35
- Confirm UDI-DI: 00858254006022 on device labeling
- Look for a Red X indicator on screen during catheter connection
Where to find product info
Manufacturers' recall notice and FDA enforcement page; serial numbers on device label
What timeline to expect
Remediation timeline not specified; expect facility-level guidance and replacement options
If the manufacturer is unresponsive
- Escalate to hospital procurement or medical device distributor
- File a complaint with FDA via MedWatch if manufacturer unresponsive
- Seek alternative vendor guidance for temporary clinical workflows
How to prevent similar issues
- Verify software version before procedures
- Maintain software update logs
- Coordinate with procurement for replacement options
- Keep records of all communications and device identifiers
Documentation advice
Retain recall notice, device labels, UDI-DI, and correspondence with vendor
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Product Details
Model VCRFG1 with software 3.35. Distributor worldwide; US distribution in multiple states listed. 1,725 units recalled.
Reported Incidents
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.
Key Facts
- Software 3.35 verification feature
- False positives temperature-dependent
- Red X indicator disables catheter
- Worldwide distribution including numerous US states
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Safety Guide
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