Events

Recall of CROSSOVER Sheath Introducer

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
    53574
  • Event Risk Class
    Class 1
  • Event Number
    Z-0087-2010
  • Event Initiated Date
    2009-10-15
  • Event Date Posted
    2009-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85892
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Cordis has received complaints of stretching or fracture of the sheath shaft during use.
  • Action
    A Medical Device Recall letter dated October 19, 2009 was issued to consignees by sending an overnight letter to each account. The letter described the affected device, issue and actions for customers. A Cordis Corporation representative will follow-up and contact consignees as necessary to facilitate obtaining signature, faxing the acknowledgement form to the Cordis Corporation, collecting and returning units. A press release from the Cordis Corporation announced a nationwide recall of the CROSSOVER Sheath Introducer available on (http://www.webwire.com/ViewPressRel.asp?aId=106460). In addition to the local sales representative, customers may contact the special Customer Service number at 1-866-854-1672, Monday through Friday from 8:30 a.m. to 8:00 p.m. Eastern Standard Time, if you have any additional questions relative to product return or alternate product.

Device

CROSSOVER Sheath Introducer
  • Model / Serial
    Catalog Number: 403545S, Lot Numbers: U0000027, U0000041 and U0000047;  Catalog Number: 403585S, Lot Number U0000025;  Catalog Number: 403645S, Lot Numbers U0000026, U0000030, U0000031, U0000038 and U0000052;  Catalog Number: 403685S, Lot Numbers U0000033, U0000042 and U0000050;  Catalog Number: 403745S, Lot Numbers U0000034, U0000035, U0000040, U0000043 and U0000055; and  Catalog Number: 403785S, Lot Numbers U0000037 and U0000046.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.
  • Product Description
    Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. || Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USA || Vital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK. || The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
  • 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