Events

Recall of Device Recall EndoPlege

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
    57522
  • Event Risk Class
    Class 2
  • Event Number
    Z-0991-2011
  • Event Initiated Date
    2010-12-03
  • Event Date Posted
    2011-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96454
  • 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 by pass - Product Code DWF
  • Reason
    Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.
  • Action
    The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated December 3, 2010 to customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to check their inventory and return the unused devices; complete and return the INTROCSC Introducer Recall Response form to the attention of Customer Service, Edwards LifeSciences, One Edwards Way, Irvine, CA at 949-250-3489. If you have any questions, please contact Edwards Customer Service at 800-424-3278 from 8:00am - 4:30pm Pacific Time.

Device

Device Recall EndoPlege
  • Model / Serial
    Lot No.: 718993, 718995, 718996, 718998, 718999, 719000, 719001, 739692, 739693, 742834, 742835, 747591, 751029, 751036, 751041, 755814, 755814A, 763115, 763119, 763123, 763125, 763127, 763128, 763129, 774333, 774334.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614. || The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the EndoPlege coronary sinus catheter contamination guard, is packaged with these catheters
  • Manufacturer
    Edwards Lifesciences Llc

Manufacturer

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