Events

Recall of Device Recall Stent Delivery Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Idev Technologies, Inc..

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
    61090
  • Event Risk Class
    Class 2
  • Event Number
    Z-1213-2012
  • Event Initiated Date
    2012-01-31
  • Event Date Posted
    2012-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107279
  • 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
    Catheter, biliary, diagnostic - Product Code FGE
  • Reason
    The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).
  • Action
    IDEV Technologies sent an "URGENT PRODUCT RECALL" letter dated February 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to sign the letter and return a copy to the firm via fax to 281-525-2001 to indicate that they have received the notification. Contact the firm at 281-525-2052 for questions regarding the notice.

Device

Device Recall Stent Delivery Catheter
  • Model / Serial
    Device Codes: S-04-120-120-G3 (Lot Number 05180062); S-04-040-120-G3 (Lot Numbers 05180031); S-04-060-120-G3 (Lot Number 05187032); S-05-040-120-G3 (Lot Number 05180034); S-05-060-120-G3 (Lot Number 05180035); S-05-080-120-G3 (Lot Number 05180036); S-05-100-120-G3 (Lot Number 05180037); and S-06-080-120-G3 (Lot Number 05180042).
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, and PA.
  • Product Description
    SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. || Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.
  • Manufacturer
    Idev Technologies, Inc.

Manufacturer

Idev Technologies, Inc.
  • Manufacturer Address
    Idev Technologies, Inc., 253 Medical Center Blvd, Webster TX 77598
  • Source
    USFDA