Bard Peripheral Vascular Inc: Electrosurgical, Cutting & Coagulation & Accessories
Updated 5 hours ago ()
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.
- Tags
- FDA recall, medical device, class 2, General, Plastic Surgery, Software Design Change, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 7: Security Operations; CISSP 8: Software Development Security
- Source record id
- Z-2638-2025
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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