Events

Recall of Device Recall PRO 2 Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AtriCure, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76017
  • Event Risk Class
    Class 2
  • Event Number
    Z-1148-2017
  • Event Initiated Date
    2016-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151944
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Clip, implantable - Product Code FZP
  • 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.

Device

Device Recall PRO 2 Device
  • Model / Serial
    Model Numbers: PRO235, PRO240, PRO245, PRO250  Lot Numbers: 67102 to 68418
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product 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.
  • Manufacturer
    AtriCure, Inc.

Manufacturer

AtriCure, Inc.
  • Manufacturer Address
    AtriCure, Inc., 7555 Innovation Way, Mason OH 45040-9695
  • Manufacturer Parent Company (2017)
    Atricure Inc
  • Source
    USFDA