Events

Recall of Aortic Arch Cannula

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group USA, 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
    74934
  • Event Risk Class
    Class 2
  • Event Number
    Z-2756-2016
  • Event Initiated Date
    2016-08-12
  • Event Date Posted
    2016-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148850
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Sorin group usa, inc. announces a voluntary field for the aortic arch cannula and coronary artery perfusion cannula with ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. samples have been returned where the angle of the tip is less than the requirement.
  • Action
    LivaNova issued an Urgent Safety Alert letter via certified mail on August 12, 2016 to all affected customers. The letter instructed customers to check their inventory to determine if the Cannulae belongs to the product code and lots listed. If the customer does not have any of the products described in the communication, please complete the response form below and return it per the instructions indicated on the form; otherwise, please check the tip angle to determine if it is conforming to specifications. If specification is not met, please file a complaint through your normal process whether you decide to keep it and use it or return the product to Sorin Group; if you are not willing to use it, return the affected parts to Sorin Group USA. Please contact Customer Service 1-S00-650-2623 or email CustomerService@livanova.com to have a Return Material Authorization (RMA) issued. Complete the Customer Response Form attached to this letter to acknowledge receipt of this letter. Please return this form no later than September 15, 2016. For questions regarding this recall call 303-467-6306.

Device

Aortic Arch Cannula
  • Model / Serial
    Lot Numbers: 1526500032, 1529300026, 1602600042.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
  • Product Description
    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. || The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA