Events

Recall of Device Recall Cordis Smart Control

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
    25712
  • Event Risk Class
    Class 2
  • Event Number
    Z-0707-03
  • Event Initiated Date
    2003-02-03
  • Event Date Posted
    2003-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26346
  • 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
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • Reason
    The smart control stent delivery system may not fully deploy or be difficult to deploy under certain circumstances.
  • Action
    The firm sent via Federal Express Overnight delivery, a notification letter entitled 'IMPORTANT PRODUCT INFORMATION ALERT' dated 2/3/2003 to all user hosptial accounts. The letter warns them of the possibility of partial deployment and how to avoid it. There is no request to stop using or to return the product. The firm considers the action a 'Safety Alert'.

Device

Device Recall Cordis Smart Control
  • Model / Serial
    All lot numbers for the referenced product numbers.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to 1141 user/medical facilities nationwide.
  • Product Description
    The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers. || Product is packed in a Tyvek pouch and further packed into a shelf carton. || Product Numbers: C06020SB, C06020MB, C06030SB, C06030MB, C06040SB, C06040MB, C06060SB, CO6060MB, C06080SB, C06080MB, C06100SB, C06100MB, C07020SB, C07020MB, C07030SB, C07030MB, C07040SB, C07040MB, C07060SB, C07060MB, C07080SB, C07080MB, C07100SB, CO7100MB, C08020SB, C08020MB, CO8030SB, C08030MB, C08040SB, C08040MB, C08060SB, C08060MB, C08080SB, C08080MB, C08100SB, C08100MB, C09020SB, C09020MB, C09030SB, C09030MB, C09040SB, C09040MB, C09060SB, C09060MB, C09080SB, C09080NB, C10020SB, C10020MB, C10030SB, C10030MB, C10040SB, C10040MB, C10060SB, C10060MB, C10080SB, C10080MB. || Product number related to dimension as follows: || C06020SB 6mm x 20mm x 80cm || C06020MB 6mm x 20mm x 120cm || C06030SB 6mm x 30mm x 80cm || C06030MB 6mm x 30mm x 120cm || C06040SB 6mm x 40mm x 80cm || C06040MB 6mm x 40mm x 120cm || C06060SB 6mm x 60mm x 80cm || C06060MB 6mm x 60mm x 120cm || C06080SB 6mm x 80mm x 80cm || C06080MB 6mm x 80mm x 120cm || C06100SB 6mm x 100mm x 80cm || C06100MB 6mm x 100mm x 120cm || C07020SB 7mm x 20mm x 80cm || C07020MB 7mm x 20mm x 120cm || C07030SB 7mm x 30mm x 80cm || C07030MB 7mm x 30mm x 120cm || C07040SB 7mm x 40mm x 80cm || C07040MB 7mm x 40mm x 120cm || C07060SB 7mm x 60mm x 80cm || C07060MB 7mm x 60mm x 120cm || C07080SB 7mm x 80mm x 80cm || C07080MB 7mm x 80mm x 120cm || C07100SB 7mm x 100mm x 80cm || C07100MB 7mm x 100mm x 120cm || C08020SB 8mm x 20mm x 80cm || C08020MB 8mm x 20mm x 120cm || C08030SB 8mm x 30mm x 80cm || C08030MB 8mm x 30mm x 120cm || C08040SB 8mm x 40mm x 80cm || C08040MB 8mm x 40mm x 120cm || C08060SB 8mm x 60mm x 80cm || C08060MB 8mm x 60mm x 120cm || C08080SB 8mm x 80mm x 80cm || C08080MB 8mm x 80mm x 120cm || C08100SB 8mm x 100mm x 80cm || C08100MB 8mm x 100mm x 120cm || C09020SB 9mm x 20mm x 80cm || C09020MB 9mm x 20mm x 120cm || C09030SB 9mm x 30mm x 80cm || C09030MB 9mm x 30mm x 120cm || C09040SB 9mm x 40mm x 80cm || C09040MB 9mm x 40mm x 120cm || C09060SB 9mm x 60mm x 80cm || C09060MB 9mm x 60mm x 120cm || C09080SB 9mm x 80mm x 80cm || C09080MB 9mm x 80mm x 120cm || C10020SB 10mm x 20mm x 80cm || C10020MB 10mm x 20mm x 120cm || C10030SB 10mm x 30mm x 80cm || C10030MB 10mm x 30mm x 120cm || C10040SB 10mm x 40mm x 80cm || C10040MB 10mm x 40mm x 120cm || C10060SB 10mm x 60mm x 80cm || C10060MB 10mm x 60mm x 120cm || C10080SB 10mm x 80mm x 80cm || C10080MB 10mm x 80mm x 120cm
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014
  • Source
    USFDA