Events

Recall of Device Recall Edwards Lifesciences Crimpers

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
    64747
  • Event Risk Class
    Class 2
  • Event Number
    Z-1135-2013
  • Event Initiated Date
    2013-03-26
  • Event Date Posted
    2013-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117023
  • 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
    Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
  • Reason
    Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
  • Action
    Edwards Lifesciences notified customers via letter and instructed them to maintain the device in its protective unit carton until ready for use and to inspect the pouch for holes or tears prior to use as instructed in the product's labeling. If any holes or tears are found, customers are instructed to contact Edwards Customer Service to arrange for return and replacement of damaged product.

Device

Device Recall Edwards Lifesciences Crimpers
  • Model / Serial
    Models 9100CR26, all lot numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
  • Product Description
    Edwards Lifesciences Crimpers, Model 9100CR26. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
  • 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