BEUDAMED
    FDA Enforcement Class II Terminated

    AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box.

    Recall: Z-1148-2017 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-1148-2017
    Event ID
    76017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AtriCure, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2017
    Initiation Date
    November 30, 2016
    Classification Date
    February 7, 2017
    Termination Date
    February 15, 2018
    Address
    7555 Innovation Way, N/A, Mason, OH, 45040-9695, United States

    Description

    AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box.

    Reason

    A complaint of the PRO2 jaw breaking prior to surgery being performed.

    Code Info

    Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418

    Distribution

    Devices were distributed in the following states: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, & WI. Devices were distributed in the following countries: Austria, Germany, Netherlands, Poland, Sweden, Switzerland and United Kingdom.

    Quantity

    464 units