Bard Peripheral Vascular Inc. is recalling 1,725 Venclose digiRF Generators (Model VCRFG1) running software version 3.35. The software contains a defect that incorrectly identifies functioning Venclose EVSRF Ablation Catheters as defective, displaying a "Red X" on the screen and disabling the catheter. This issue occurs when the catheter's temperature is not stable during the automated connection check.
The software error causes false-positive failures that disable properly functioning medical catheters immediately before a procedure. This can lead to clinical delays, the loss of usable medical supplies, and the potential need for alternative treatment options during a scheduled surgery.
Affected units are specifically those running Software Version 3.35.
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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