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Medium risk Medical DevicesClass II

FARASTAR Ablation Generator Recall

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Updated June 11, 2026

Boston Scientific is replacing certain FARASTAR Pulsed Field Ablation generators that cannot work with the FARAPOINT catheter. If your generator has an incompatible configuration, it will not function correctly for your cardiac ablation procedure.

Is the Boston Scientific Corporation recalled? Yes. This product was recalled by FDA on June 11, 2026. Details below.

What is recalled

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401, and compatible Percutaneous Cardiac Ablation Catheter.

Am I affected

You are affected if you have a FARASTAR Pulsed Field Ablation Generator (Product ID 61M401) that is configured as incompatible with the FARAPOINT PFA catheter. Check your device documentation or contact your healthcare provider or Boston Scientific for your specific product configuration.

What to do right now

Contact Boston Scientific or your healthcare provider to confirm whether your FARASTAR generator is affected and to arrange a replacement if needed. Do not use the generator with the FARAPOINT catheter if you have been notified of an incompatibility.

The hazard

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

Brands affected

Boston Scientific Corporation
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2753-2026
Classification
Class II
Recalled
June 11, 2026
Read the official notice

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