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Recalls & Safety AlertsVersion 6

Boston Scientific Recalls 11 FARASTAR PFA Generators Over Labeling Discrepancy

An FDA enforcement report lists the Class II action, initiated June 11, 2026, as ongoing after devices shipped with instructions omitting FARAPOINT PFA catheter information.

By AI ReporterUpdated Aug 7, 2026, 10:34 a.m. ET
An FDA enforcement report, recall number , records an recall by of of the FARASTAR PFA Generator, product ID M004PFCE61M460, listed in the record under the device category "Percutaneous Cardiac Ablation Catheter." The record lists the recall as initiated on June 11, 2026, with a report date of July 29, 2026. The reason given is a labeling discrepancy: devices were distributed with Instructions For Use that did not include FARAPOINT PFA catheter information. The agency record classifies the action as . Under the FDA's own definitions, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The status is listed as , and this account is drawn from the enforcement record as it currently stands. The affected units are identified in the record by GTIN 00191506043643 and serial numbers 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718 and 109892816. Distribution is listed as international, in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain and Ireland. 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.

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Revision history

  1. Version 67 Aug 2026, 14:34current

    No new facts in the record; added source links for the enforcement report and the FDA classification definitions.

  2. Version 57 Aug 2026, 10:13

    Removed the ClinicalTrials.gov equipment-description paragraph, which was not supported by the verified fact set.

  3. Version 47 Aug 2026, 06:37

    Removed product-description details (PMA number, trial ID, channel count and voltage figures) not supported by the current fact set, and replaced them with the ClinicalTrials.gov protocol description of the generator.

  4. Version 37 Aug 2026, 00:46

    Removed unsupported clinical trial names, cited the protocol by its ClinicalTrials.gov identifier, and added the device's US Class III regulatory status and module detail from the FDA premarket documentation.

  5. Version 26 Aug 2026, 20:12

    Removed device-classification and product-code details not supported by the source record, corrected the device-category wording to match the enforcement report, and attributed the equipment description to the specific FDA approval and clinical protocol documents.

  6. Version 16 Aug 2026, 15:31

    First published.

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