Recall Z-2638-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bard Peripheral Vascular Inc
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 catheter
| Date | Sep 26, 2025 (initiated Aug 21, 2025) |
| Status | Open, Classified |
| Reason | 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 soft |
| 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 r |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) Venclose, Inc., Sep 9, 2016 |
| K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter Venclose, Inc., Aug 3, 2021 |
| K250068 | Venclose digiRF Generator (VCRFG1) Venclose, Inc., Feb 4, 2025 |