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Recalls & Safety AlertsVersion 6

Boston Scientific Recalls One FARASTAR Ablation Generator Over Missing Catheter Instructions

An FDA enforcement report says instructions supplied with the device omitted FARAPOINT PFA catheter information; the Class II action is listed as ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:15 a.m. ET
has recalled a FARASTAR Pulsed Field Ablation Generator because the Instructions For Use supplied with the device did not include FARAPOINT PFA catheter information, according to an FDA enforcement report carrying recall number . The record lists the firm-initiated date as June 11, 2026, and the report date as July 29, 2026. The recall is listed as . The enforcement report describes the product as the FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401, a percutaneous cardiac ablation catheter device, identified by GTIN 00191506042547 and serial number 106247020. The quantity is given as "", with international distribution in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain and Ireland. The FDA classified the action as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The equipment is hospital electrophysiology hardware rather than anything a member of the public can buy. Background material describes it as a mains-powered, cart-mounted console used with a flexible single-use catheter and connecting cables, sold business-to-business to hospitals and installed by a trained representative of the manufacturer. China's National Medical Products Administration, which has separately approved the FARAWAVE catheter and FARASTAR generator system for marketing, describes the system as a pulsed electric field ablator with a recording module and accessory cables, paired with a catheter and catheter connection cable. A clinical study protocol filed on ClinicalTrials.gov describes the generator as a 12-channel output unit producing a user-selectable pulsed high-voltage waveform in the region of 1,800-2,000 volts, delivered through the attached catheter, which a physician passes through a puncture in a blood vessel to the inner surface of the heart. FDA device labelling states it is a prescription device for use only in a fully equipped electrophysiology lab by physicians trained in invasive cardiology and catheter techniques. None of that background bears on this recall. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action. The recall remains open and the record may be updated.

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Revision history

  1. Version 67 Aug 2026, 14:15current

    Added that the generator is sold to hospitals and installed by a trained manufacturer representative; no changes to recall facts.

  2. Version 57 Aug 2026, 11:42

    Added FDA device-labelling detail on prescription status and trained-physician/EP-lab use, and trimmed the unsourced voltage-step figure to the range given in reference data.

  3. Version 47 Aug 2026, 05:21

    Removed device specifications (US premarket approval number, catheter dimensions, spline and electrode counts, model-reference interpretation) not supported by the cited records, and re-attributed the remaining product description to the NMPA approval notice and the ClinicalTrials.gov protocol.

  4. Version 37 Aug 2026, 02:08

    Corrected device description to the sourced reference data (voltage range, 12 French shaft, 20 electrodes, 31 mm version), quoted the record's "1 units" wording verbatim, removed the unsourced February 2025 NMPA date and unsupported catheter details, and added the FDA premarket approval document as a cited source.

  5. Version 26 Aug 2026, 21:31

    Expanded the product description with the filed trial-protocol specifications (12-channel console, catheter construction and sizes) and the US premarket approval number, and added the ClinicalTrials.gov protocol sources.

  6. Version 16 Aug 2026, 17:10

    First published.

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