BEUDAMED
    FDA Recall Terminated

    Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

    Recall: Z-0381-2022 · Initiated November 8, 2021

    Recall

    Recall Number
    Z-0381-2022
    Event Number
    89034
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    MCX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 8, 2021
    Terminated
    May 2, 2023
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

    Reason

    Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.

    Action

    The recalling firm issued letters dated 11/8/2021 on the same date and flagged "Urgent Medical Device Removal - Immediate Action Required." It explains the reason for recall, the risk to health, and provides removal instructions. The instructions say to immediately discontinue use of and segregate the affected product. A Reply Verification Tracking Form is enclosed for immediate completion and return. The customer will be contacted by BSC and provided a Returned Goods Authorization for return of the device.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.

    Quantity

    7 devices