Events

Recall of FLEXSTENT Femoropopliteal SelfExpanding Stent System (Clinical Study Protocol FSS0003 (OPEN trial)

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

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
    65182
  • Event Risk Class
    Class 2
  • Event Number
    Z-1508-2013
  • Event Initiated Date
    2013-04-23
  • Event Date Posted
    2013-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118150
  • 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, biliary, diagnostic - Product Code NIP
  • Reason
    Holes and/or tears can be introduced in the flexstent¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
  • Action
    Cordis sent an Urgent Medical Device Correction and Potential Removal letter dated April 24, 2013 e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected products to prevent further use of the affected product, until inspected. ¿ Use only product identified with a blue dot next to the lot number on the carton face label, carton end label, and outer pouch label, or product with upgraded sterile barrier system (not yet available, as of the date of this letter), review, complete, sign and return the enclosed Acknowledgement Form and maintain a copy of this notice with the affected product. For questions related to the issue, please contact our FSS/Cordis representative, or please contact Cordis Direct at (800) 781-0282, Monday through Friday from 9:00 AM to 5:00 PM EDT.

Device

FLEXSTENT Femoropopliteal SelfExpanding Stent System (Clinical Study Protocol FSS0003 (OPEN trial)
  • Model / Serial
    28 Catalog Numbers   CAC-50030-V2, CAC-60030-V2, CAC-70030-V2, CAC-80030-V2, CAC-50040-V2, CAC-60040-V2, CAC-70040-V2, CAC-80040-V2, CAC-50060-V2, CAC-60060-V2, CAC-70060-V2, CAC-80060-V2, CAC-50080-V2, CAC-60080-V2, CAC-70080-V2, CAC-80080-V2, CAC-50100-V2, CAC-60100-V2, CAC-70100-V2, CAC-80100-V2, CAC-50120-V2, CAC-60120-V2, CAC-70120-V2, CAC-80120-V2, CAC-50150-V2, CAC-60150-V2, CAC-70150-V2, CAC-80150-V2
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
  • Product Description
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. || Product Usage: || The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA