BEUDAMED
    FDA Enforcement Class II Terminated

    ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.

    Recall: Z-0870-2021 · Reported January 27, 2021

    Enforcement

    Recall Number
    Z-0870-2021
    Event ID
    87033
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    January 27, 2021
    Initiation Date
    December 15, 2020
    Classification Date
    January 15, 2021
    Termination Date
    August 14, 2023
    Address
    4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.

    Reason

    Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.

    Code Info

    GTIN 08714729936176, Lot Number H1937249

    Distribution

    US Nationwide distribution including in the states of Tulsa, OK.

    Quantity

    5 units