Z-2638-2025Class II

Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies...

Name: Z-2638-2025 Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies...
Creator: Bard Peripheral Vascular Inc
Published: 2025-08-21
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2025-08-21 / Open, Classified / root cause: software

FDA source

Bard Peripheral Vascular Inc began a recall of Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to... on 2025-08-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2638-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-21
Posted: 2025-09-26
Recalling firm: Bard Peripheral Vascular Inc
Product: Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 8/21/2025, correction notices were mailed or emailed to Health Care Professionals (HCPs), Risk Manager, Head Nurse, Nurse Manager, Medical Device Safety Officer, Procurement Officer, Office Manager, and Distributors, were advised of the following: If the generator is operating with affected software and is connected to a catheter and the software check fails, a red "X" will be displayed on the generator screen without an accompanying error code Actions: 1) Firm Representative will contact your facility to arrange the restoration of your facility's generator to software version 3.17 upon receiving regulatory clearance of the 510(k) premarket notification. 2) Your facility will become eligible to receive future shipments of Venclose EVSRF Ablation Catheters only after the Venclose digiRF Generator has been verified to run software version 3.17. 3) Complete and return the customer response form via email to [email protected] 4) Post the Customer Notification Letter on or near the generator until the software has been restored to software version 3.17 by a firm representative. 5) Share this notification with all product users within your facility network to ensure they are also aware of this product correction. If the affected products have been distributed further, please ensure that these entities are contacted and informed of the recall. Please contact your firm representative if you require additional assistance with this process: North American Regional Complaint Center, 1-844-823-5433, [email protected]
Quantity in commerce: 1,725
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, AR and the country of Malaysia.
Product codes and lots: UDI-DI: 00858254006022. Generator Software Version 3.35

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2638-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2638-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-09-26

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)