Boston Scientific Corporation — Class II: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percut
Boston Scientific is conducting a Class II recall to replace specific FARASTAR Pulsed Field Ablation (PFA) generators (Product ID 61M401) because their current configuration is incompatible with the FARAPOINT PFA catheter.
Boston Scientific Corporation, users of the FARASTAR Ablation Generator EU (Product ID 61M401), and clinical staff utilizing Pulsed Field Ablation systems.
This action highlights a configuration-based compatibility risk within a PFA system, which could lead to procedural delays or equipment failure if incompatible components are used together. For regulatory professionals, it underscores the importance of verifying hardware-software or hardware-accessory compatibility across international product configurations (EU designation) and the necessity of robust field-replacement protocols when specific hardware versions do not support newer accessories.
QA and clinical engineering teams should verify current FARASTAR Ablation Generator inventory against Product ID 61M401 and assess compatibility with FARAPOINT PFA catheters. Regulatory teams should document the replacement process within their CAPA or field action tracking systems to ensure all incompatible units are identified and exchanged.
Class II. Reason: Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.. Product: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter. Firm: Boston Scientific Corporation (Saint Paul MN United States). Status: Ongoing.
Open in openFDA / FDA.gov