Events

Recall of Device Recall SUPERA VERITAS

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
    65245
  • Event Risk Class
    Class 2
  • Event Number
    Z-1550-2013
  • Event Initiated Date
    2012-05-29
  • Event Date Posted
    2013-06-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118359
  • 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
    There was an error on the outer labeling of this device. the inner label was correct.
  • Action
    The firm decided to rework the products that were in their control at the time and the one that was not in their control was corrected by an IDEV employee. That hospital was called and notified of the situation in May 2012.

Device

Device Recall SUPERA VERITAS
  • Model / Serial
    Model Number: S-05-100-120-G3; Lot Number 01049037
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to the states of FL, NY, and PA.
  • Product Description
    IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated 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 77598-4213
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA