Events

Safety Alert for AMPLATZER TorqVue FX Delivery System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by St Jude Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-02-14
  • Event Date Posted
    2013-02-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130214a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: st jude medical amplatzer torqvue fx delivery system the food and drugs administration (fda), united states posted a medical device safety alert concerning amplatzer torqvue fx delivery system [model no.: 9-itvfx06f45/60, 9-itvfx07f45/60, 9-itvfx007f45/80, 9-itvfx08f45/60, 9-itvfx08f45/80, 9-itvfx09f45/80, 9-itvfx10f45/80, 9-itvfx12f45/80, 9-itvfx13f45/80] manufactured by st jude medical. the product was manufactured 24 august 2012 to 24 september 2012 and distributed 1 october 2012 – 9 january 2013. in a small number of cases, the distal end of the core wire of the torqvue fx delivery system could potentially fracture. this product may cause serious adverse health consequences, including death. the manufacturer advised customers to stop using the device and remove it from their inventory. according to the local supplier, the affected devices were not distributed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm339458.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 14 february 2013.

Device

AMPLATZER TorqVue FX Delivery System

Manufacturer

St Jude Medical
  • 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
    DH