Venclose digiRF Generator Software Version 3.35 Causes False Positive Catheter Failures
The Venclose digiRF Generator software version 3.35 mistakenly disables properly working catheters due to faulty temperature checks. Approximately 1,725 units distributed in the US and Malaysia are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a software malfunction. The recall notice contains no reports of injuries or illnesses. Per the rubric, risk-of-harm products where injury is not reported score as 3.
Plain-English summary
The Venclose digiRF Generator is a radiofrequency ablation device used to treat incompetent veins. Software version 3.35 includes an automated catheter verification feature designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters before clinical use.
The software generates false positive failures due to temperature-dependent verification parameters. When the catheter temperature is not at steady state during the verification check, the generator incorrectly identifies properly functioning catheters as defective, displays a Red X on the screen, and disables catheter functionality, preventing device use.
Approximately 1,725 units with software version 3.35 have been distributed worldwide, including throughout the US and Malaysia. Healthcare providers should contact Bard Peripheral Vascular Inc regarding affected units and for guidance on available remedies.
The recalled product
- 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 th
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- software-malfunction
- false-positive
- device-disabling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00858254006022. Generator Software Version 3.35
Distribution
Distributed nationwide across the United States.
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