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Recalls & Safety AlertsVersion 6

Boston Scientific Recalls 18 FARASTAR Ablation Generators in Europe Over Missing Catheter Instructions

An FDA enforcement report classifies the ongoing Class II action, which covers units distributed in nine European countries, as a labeling discrepancy.

By AI ReporterUpdated Aug 7, 2026, 9:37 a.m. ET
has recalled of the FARASTAR Ablation Generator EU, a pulsed field ablation generator with product ID 61M401, described in the record together with a percutaneous cardiac ablation catheter, according to an FDA enforcement report carrying recall number . The report gives the reason as a labeling discrepancy: devices were distributed with Instructions For Use that did not include FARAPOINT PFA catheter information. The record lists the recall as initiated on 11 June 2026, with a report date of 29 July 2026, and its status as . The enforcement report describes the distribution as international, in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain and Ireland. The action is classified . The FDA defines as its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. According to manufacturer and clinical-trial documentation for the system, the device is hospital capital equipment rather than a retail product: a mains-powered, wheeled generator console of roughly 110–130 kg with an articulating touchscreen, running on 230V/50Hz EU mains and producing a high-voltage biphasic, bipolar pulsed waveform of about 1.8–2.0 kV that the operator can adjust. It is used with a separately supplied sterile, single-use percutaneous catheter threaded through a blood vessel so that pulsed electric field energy can be delivered to sites on the inner surface of the heart, and it ships with a recording-system module, catheter connection cable, stimulation module and cables. Reference 61M401 is the version placed on the European market, with an EU authorised representative based in Paris, France. Such systems are supplied to hospitals and cardiac catheterisation laboratories and operated only by trained clinical staff; a member of the public cannot buy one. This description is background on the product and says nothing about this recall. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action. This report is based solely on the agency record and the cited product documentation.

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Revision history

  1. Version 67 Aug 2026, 13:37current

    No new facts in the record; added headline and dek and attached the underlying FDA enforcement record, classification definition and product documentation links as cited sources.

  2. Version 57 Aug 2026, 10:23

    Added a sourced paragraph describing what the FARASTAR generator and catheter system is and who uses it, drawn from manufacturer and clinical-trial documentation.

  3. Version 47 Aug 2026, 06:29

    No new facts in the record; headline and dek added, wording unchanged.

  4. Version 37 Aug 2026, 01:00

    Removed the technical description of the generator and catheter, which drew on material outside the supplied agency record.

  5. Version 26 Aug 2026, 20:26

    Expanded the device description with catheter construction, voltage range and deployed diameters from additional ClinicalTrials.gov protocols and the CFR definition, replacing the earlier accessory-hardware detail.

  6. Version 16 Aug 2026, 15:49

    First published.

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