Bard Peripheral Vascular Inc. is recalling approximately 222,373 Venclose RF Ablation Catheters due to an internal wiring error where the red and yellow signal wires were accidentally swapped. This manufacturing defect can cause the device to overheat and exceed safe temperatures while the control console falsely indicates that the target temperature has not yet been reached. The recall affects several models and catalog numbers including the VC-10A2.5 and VCOUS series, which were distributed worldwide to hospitals and vascular clinics between 2024 and 2026. No injuries have been reported at this time.
The swapped wiring causes the device's generator to bypass safety sensors and overdrive the catheter's heating element, leading to temperatures far higher than intended for therapeutic use. This poses a high risk of internal thermal injury to patients because medical staff may be unaware the device is overheating due to incorrect temperature readings on the display console.
Sterile, single-use disposable medical device for endovenous radiofrequency ablation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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