Events

Recall of Device Recall Crimper

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
    67362
  • Event Risk Class
    Class 2
  • Event Number
    Z-0918-2014
  • Event Initiated Date
    2014-01-20
  • Event Date Posted
    2014-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125336
  • 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
    Edwards lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. as a result, user may have difficulty fitting a 26mm sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
  • Action
    Edwards Lifesciences issued an Urgent Product Notice to all customers. Letters were sent via Fed Ex on 01/20/14. The letter outlines steps to be taken to enable a valve to fit into the open orifice, and allow the valve to be crimped according to normal instructions. Customers were instructed to forward the Urgent Product Notification letter to necessary personnel within their organization. Customers were also instructed to acknowledge they have reviewed and understand the notification letter by signing and dating the form included with the letter. Customers with questions were instructed to contact their Edwards Clinical Specialist.

Device

Device Recall Crimper
  • Model / Serial
    lot 59617777 and 59658495.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Crimper Model 9100CR26 || The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
  • 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