Events

Recall of Device Recall AtriCure Reusable Clip Applier

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
    67572
  • Event Risk Class
    Class 2
  • Event Number
    Z-1209-2014
  • Event Initiated Date
    2014-01-23
  • Event Date Posted
    2014-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125737
  • 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
    Applier, hemostatic clip - Product Code HBT
  • Reason
    The firm was notified by a customer of a cracked spring in the handle of the rcd1 device.
  • Action
    On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.

Device

Device Recall AtriCure Reusable Clip Applier
  • Model / Serial
    Lot Number MFR-0424-1
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.
  • Product Description
    Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. || The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.
  • Manufacturer
    Atricure Inc

Manufacturer

Atricure Inc
  • Manufacturer Address
    Atricure Inc, 6217 Centre Park Drive, West Chester OH 45069
  • Manufacturer Parent Company (2017)
    Atricure Inc
  • Source
    USFDA