Events

Recall of Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System

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
    47347
  • Event Risk Class
    Class 2
  • Event Number
    Z-1556-2008
  • Event Initiated Date
    2008-03-10
  • Event Date Posted
    2008-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69267
  • 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
    Iliac Stent - Product Code NIO
  • Reason
    Data transcription error. the 10 affected lots of catalog number c10040sl were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. this condition may result in a separation of the device. if a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel.
  • Action
    A letter (RE: Medical Device Recall) dated March 11, 2008, and Acknowledgement Form was sent overnight to the following 6 individuals in each account: Dir. Cardiac Cath Lab, Dir. Radiology Services, Dir. Vascular Services, Risk Manager, Materials Dir., Hospital Administrator; requesting that the affected product be set aside, and that the form be reviewed, signed, and faxed back to Cordis. Affected product is to be either returned or the local sales rep should the contacted to facilitate the return of the affected product. All product will be replaced. Customer Service can be contacted if there are additional questions relative to product return, replacement, or availability.

Device

Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System
  • Model / Serial
    10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution --- including USA and countries of Japan and Canada.
  • Product Description
    CORDIS S.M.A.R.T.¿ Control" Nitinol Stent System || Model Number(s): C10040SL, Manufactured in Mexico. || Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 NW 60th Avenue, Miami Lakes FL 33014
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA