Events

Recall of Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories

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
    64404
  • Event Risk Class
    Class 2
  • Event Number
    Z-0912-2013
  • Event Initiated Date
    2013-01-14
  • Event Date Posted
    2013-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116050
  • 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
    Surgical device, for ablation of cardiac tissue - Product Code OCL
  • Reason
    Products from lot no. 41865 may have been sent out with incorrect instructions for use (ifu) labeling.
  • Action
    AtriCure sent a Urgent Medical Device Recall/Correction letter dated January 14, 2013, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. If the MAX1 is used as intended there is no risk to the patient as a result of this issue. The correct instructions for Use for the MAX1 Pen is included with this notification. AtriCure will replace any affected product if requested by the facility. Please review and fill out the attached " Acknowledgement Form" and either fax to AtriCure at (513) 644-4753. If you need to contact customer service, their number is 1-866-349-2342.

Device

Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories
  • Model / Serial
    Model Number(s): MAX1 A000163, Lot Number 41865
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of MD, PA and TX.
  • Product Description
    Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
  • 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