Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators with software version 3.35. The recall centers on a catheter verification feature that can produce false positives and disable compatible EVSRF catheters. The worldwide distribution includes the United States. Patients and healthcare providers should stop using the device and await further instructions from the manufacturer.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Bard Peripheral Vascular Inc or your healthcare provider for instructions. Notification method: Letter
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Venclose digiRF Generator is a multi-voltage RF energy delivery system used with Venclose EVSRF Ablation Catheters for temperature-controlled vein ablation.
Software 3.35 verification may falsely flag working catheters as defective, disabling use before procedures begin.
This recall is not described as part of a broader industry pattern.
High hazard potential due to device functioning being disabled pre-procedure, requiring clinical oversight and potential schedule disruption.
Manufacturers' recall notice and FDA enforcement page; serial numbers on device label
Remediation timeline not specified; expect facility-level guidance and replacement options
Retain recall notice, device labels, UDI-DI, and correspondence with vendor
Model VCRFG1 with software 3.35. Distributor worldwide; US distribution in multiple states listed. 1,725 units recalled.
No specific injuries or patient harm data are provided in the recall notice. This entry notes a high-hazard warning but does not report injuries.
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