Events

Recall of Device Recall Cordis Precise Nitinol Stent

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
    25043
  • Event Risk Class
    Class 2
  • Event Number
    Z-0323-03
  • Event Initiated Date
    2002-11-07
  • Event Date Posted
    2002-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25052
  • 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
    Field complaints of marker band spacing being out of spec.
  • Action
    The firm sent, via First Class Mail, a Recall notification Letter with Response Card on 11/7/02. The letter asks for response from the user accounts and for return of product. The letter includes a UPS label for return of product. Non-responders will be recontacted as part of the firm''s effectiveness checks.

Device

Device Recall Cordis Precise Nitinol Stent
  • Model / Serial
    All lot numbers of the indicated Product/Catalog numbers.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to 620 hospital accounts nationwide. The firm did not provide information on international accounts. This info was requested from firm and RES will be updated when available.
  • Product Description
    Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB, N830SB, N840SB, N920SB, N930SB, N940SB, N1020SB, N1030SB, N1040SB only. This recall also affects Cordis PRECISE Nitinol Stent System, not distributed in the United States, Catalog numbers, N920SC, N930SC, N940SC, N1020SC, N1030SC and N1040SC only.
  • Manufacturer
    Cordis Corporation

Manufacturer

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