Events

Recall of Device Recall ThruPort Knot Pusher

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

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
    72046
  • Event Risk Class
    Class 2
  • Event Number
    Z-2780-2015
  • Event Initiated Date
    2015-08-26
  • Event Date Posted
    2015-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139667
  • 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
    Probe Blood-Flow extra vascular - Product Code DPT
  • Reason
    The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.
  • Action
    Edwards sent an Urgent-Product Recall - Action Required letter dated August 26, 2015, to all affected customers. Letters were sent via Fed-Ex. Please check your inventory for the affected Lot Numbers listed above and return the enclosed confirmation form. If your inventory includes affected product, please contact Edwards Lifesciences to obtain an RGA number and return the affected product. We apologize for the inconvenience caused by this action and appreciate your attention to this matter. If you have questions that have not been answered by this letter, please call Edwards Customer Service at (800) 424-3278 from 6:00AM  4:30PM Pacific Time.

Device

Device Recall ThruPort Knot Pusher
  • Model / Serial
    Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865  Model VPP Lot No: 60022521, 60022522, 60064112
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.
  • Product Description
    ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. || The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Manufacturer Address
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Manufacturer Parent Company (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA