Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Vencl

FDA device recall Z-2638-2025 · posted 2025-09-26 · Open, Classified

Recall details

Recalling firm

Bard Peripheral Vascular Inc

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.

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

Root cause

Software Design Change

Status

Open, Classified

Product code

GEI

Quantity affected

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

Date initiated

2025-08-21

Date posted

2025-09-26

Location

Tempe, AZ

Related 510(k) clearances