BEUDAMED
    FDA Recall 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 · Initiated November 30, 2016

    Recall

    Recall Number
    Z-1148-2017
    Event Number
    76017
    Firm
    AtriCure, Inc.
    FEI Number
    3011706110
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 30, 2016
    Terminated
    February 15, 2018
    Address
    7555 Innovation Way, Mason, OH, 45040-9695

    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.

    Action

    Recall notification letters were mailed to all Atricure customers. Email notification letters were forwarded to all Atricure field-based personnel, who may also conduct in-person meetings. Telephone calls will be made as needed and effectiveness checks will be conducted.

    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