⚠ Recalls found. FARASTAR Ablation Generator EU is named in 2 official recalls in our current data:
FDA Class II recall Z-2750-2026 — Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA Class II recall Z-2753-2026 — Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.