Vein ablation generators recalled over software falsely flagging working catheters
BD is recalling 1,725 Venclose digiRF generators running software 3.35 because the catheter verification check produces false positive failures on properly functioning catheters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the stated effect is a false positive that disables a working catheter before use, an availability problem with no hazard or injury described.
Plain-English summary
Venclose digiRF Generators, model VCRFG1, running software version 3.35 are being recalled. The generator is a multi-voltage energy delivery system that uses resistive radiofrequency ablation to deliver temperature-controlled energy to incompetent vein walls, and is used with Venclose EVSRF or Maven radiofrequency catheters.
Software version 3.35 includes a catheter verification feature designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters before clinical use. The check runs as soon as a catheter is connected, before the procedure interface becomes accessible, and a catheter that fails is shown with a red X indicator and no accompanying error code, which disables its functionality. BD has determined that version 3.35 generates false positive failures because the verification parameters are temperature-dependent, so properly functioning catheters are incorrectly flagged as defective when the catheter temperature is not at steady state when the check begins.
The recall covers 1,725 generators carrying UDI-DI 00858254006022, distributed worldwide including in New Jersey, New York, Florida, Louisiana, Virginia, California, Texas, Nevada, Pennsylvania, Nebraska and Tennessee. The FDA has classified the action as Class II.
Sites using affected generators should follow BD's instructions for the software issue. The enforcement record describes catheters being wrongly rejected rather than a defect in the energy delivered.
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…
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 1,725
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
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