Boston Scientific FARASTAR PFA Generator
Boston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.
Healthcare providers should immediately stop using the affected FARASTAR PFA generators with FARAPOINT PFA catheters and contact Boston Scientific for replacement units.
Why it was recalled
Boston Scientific is recalling specific FARASTAR Pulsed Field Ablation (PFA) generators because they possess a configuration that is incompatible for use with the FARAPOINT PFA catheter. The affected units are identified by Product ID 61M401.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · last updated 2026-07-20 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification