Events

Recall of Device Recall CORDIS Peripheral Steerable Guidewire

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
    35940
  • Event Risk Class
    Class 2
  • Event Number
    Z-1493-06
  • Event Initiated Date
    2006-07-21
  • Event Date Posted
    2006-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47238
  • 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
    Peripheral Steerable Guidewire - Product Code DXQ
  • Reason
    Tip separation-cordis sv-5 and sv-8 steerable guidewires may have a potential for guidewire fracture resulting in tip separation.
  • Action
    A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06.

Device

Device Recall CORDIS Peripheral Steerable Guidewire
  • Model / Serial
    70905743 70905744 70905745 70206756 70206758 70206759 70306719 70306720 70306792 70306822 70306849 70406715 70406768 70406796 70506745 70506753 70506754 70506755
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands
  • Product Description
    CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,Cordis a Johnson Johnson Company ,ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503558X
  • 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