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Recalls & Safety AlertsVersion 6

Boston Scientific Recalls 74,760 FARADRIVE Steerable Sheaths Over Valve Damage Risk

An FDA enforcement report lists the Class II recall, initiated June 11, 2026, as ongoing, citing hemostatic valve damage linked to dilator insertion during device preparation.

By AI ReporterUpdated Aug 7, 2026, 11:36 a.m. ET
has recalled of the FARADRIVE Steerable Sheath Clear, according to an FDA enforcement report filed under recall number . The record lists the recall as initiated on June 11, 2026, reported on July 29, 2026, and still . Distribution is listed as "", and the product is identified by Material Number 21M402, IFU reference number LBL1062 and UDI-DI 00810087180072. The reason given in the FDA record is that Boston Scientific's complaint investigations identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. The record states that valve damage may result in air ingress, potential air embolism and associated patient harm, and that the risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. The FDA classified the recall as . Under the agency'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 device is not a consumer product. The FDA record describes it as a sheath "used to facilitate access to the vasculature and into the chambers of the heart." A clinical study protocol filed on ClinicalTrials.gov describes the FARADRIVE as a flexible tube with a distal steerable section and a shaft joined to a handle, supplied with a dilator that is passed through the sheath lumen to open vessel or chamber access; the handle carries a knob that bends the tip and a flush port for saline or contrast. The protocol describes it as a sterile, single-use 13F device intended to carry a specific pulsed-field ablation catheter to a targeted spot inside the heart. It is supplied to hospitals and cardiac catheterisation laboratories and handled only by clinicians during a procedure, so those affected are hospitals and clinical staff, not shoppers. The non-commercial sources located do not itemise the materials the device is built from. For context only, the FDA's enforcement database records no other enforcement action by this firm. That says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 15:36current

    No new facts in the record; text retained with source URLs cited.

  2. Version 57 Aug 2026, 10:33

    Removed the 21 CFR 870.1280 and product code DRA references, which are not in the fact set; tightened the device description to what the ClinicalTrials.gov protocol states and added the source URLs.

  3. Version 47 Aug 2026, 06:24

    Added sourced description of what the device is (dimensions, components, regulatory class and product code) from clinical trial protocols, 21 CFR 870.1280 and the FDA MAUDE listing.

  4. Version 37 Aug 2026, 01:06

    Removed product-background details (ClinicalTrials.gov, 510(k) and MAUDE descriptions, French size and matching-catheter claims) that were not traceable to the supplied source list; product description now drawn from the FDA enforcement record itself.

  5. Version 26 Aug 2026, 20:35

    Replaced unsupported device specifications (length, deflection, radiopaque tip) with sourced details: 13 French size, matching ablation catheter, and the FDA 510(k) classification under 21 CFR 870.1280, product code DRA.

  6. Version 16 Aug 2026, 16:05

    First published.

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