Recall Z-2638-2025
Bard Peripheral Vascular Inc · initiated August 21, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: UDI-DI: 00858254006022. Generator Software Version 3.35
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.
FDA-determined cause: Software Design Change
Action taken
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 BDRC14@bd.com 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, productcomplaints@bd.com
Details
- Recall number
- Z-2638-2025
- Initiated
- August 21, 2025
- Posted by FDA
- September 26, 2025
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 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.
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ