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Boston Scientific Replacing Six FARASTAR Ablation Generators in Europe Over Catheter Incompatibility

An FDA enforcement report lists a Class II action covering six pulsed field ablation generators distributed in five European countries.

By AI ReporterUpdated Aug 7, 2026, 11:08 a.m. ET
is replacing six FARASTAR Ablation Generator EU units — pulsed field ablation generators, Product ID 61M401 — because of a configuration that is not compatible for use with the FARAPOINT PFA catheter, according to the FDA enforcement report filed under recall number . The record lists the firm's action as initiated on June 11, 2026, and reported on July 29, 2026, with a status of . The enforcement record classifies the action as and lists international distribution in Italy, Austria, France, Germany and Belgium. Under the FDA's own published definitions, is the agency's middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The affected units are identified in the record by GTIN/UDI 00810087180126 and serial numbers 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107 and 1-229-0172. The record also describes the product as a percutaneous cardiac ablation catheter. This is hospital equipment rather than a consumer product. Clinical trial protocols hosted by ClinicalTrials.gov, an FDA device regulation for percutaneous catheters and a review of pulsed field ablation published by the National Institutes of Health describe the generator as a mains-powered console on wheels with a touchscreen, running on 230 V / 50 Hz in the EU, housing multi-channel high-voltage electronics, a recording-system module, electrogram and ECG input and output modules and connecting cables, and producing short, high-voltage bipolar, biphasic electrical pulses. The console does nothing on its own: it is wired to a long, thin, flexible polymer catheter carrying metal electrodes at its tip, which a physician passes through the skin into a vein or artery, using an introducer sheath or guide wire, and advances to the inner surface of the heart. The catheter is the sterile, single-use, prescription-only part; the generator is capital equipment installed in procedure rooms at hospitals and cardiac catheterisation and electrophysiology laboratories, and both are handled only by trained clinical staff. Devices of this type are CE-marked for the European market, with an EU authorised representative based in France. A member of the public cannot buy either item. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action, and the record is a developing one: the recall's status is listed as .

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Revision history

  1. Version 67 Aug 2026, 15:08current

    Added the CE marking and France-based EU authorised representative detail and the introducer sheath/guide wire description from the product background; trimmed the redundant Product ID line.

  2. Version 57 Aug 2026, 10:31

    Replaced unsupported device specifications (12-channel, 1400-2000 volts, NMPA material) with the sourced description of the generator and catheter, and corrected source attribution.

  3. Version 47 Aug 2026, 06:25

    Corrected device-description sourcing to the ClinicalTrials.gov protocols and China's NMPA approval notice (removing unsupported references to PMA P230030 and the ADVENT trial), added the generator's stated 1400-2000 volt output range and the catheter product description.

  4. Version 37 Aug 2026, 01:05

    Removed the unsourced "user-selectable voltage settings" detail and re-grounded the device description in the FDA PMA summary and both ClinicalTrials.gov protocols.

  5. Version 26 Aug 2026, 20:32

    Replaced unsourced device specifications (12F size, 115 cm length, electrode and spline counts, sterilisation claims) with the ADVENT trial protocol's description, attributed and linked.

  6. Version 16 Aug 2026, 16:02

    First published.

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