Events

Recall of NC Trek Rx Coronary Dilatation System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abbott Vascular Division of Abbott Australasia Pty Ltd.

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
    RC-2017-RN-00402-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-03-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00402-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Specific lots of the nc trek rx coronary dilatation catheter have been identified to potentially exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. the worldwide frequency of tight sheath removal, inflation and deflation reported events is 0.12%. potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. in one reported case, failure to deflate the balloon necessitated surgery, leading to multiple post-operative complications and death. please note that this action does not affect patients having successfully undergone cardiac procedures using these devices.
  • Action
    Abbott Vascular is advising users to refer to the list of affected part numbers and lot numbers in their recall letter. If affected stock is identified, users are requested to immediately cease using these devices, complete and return the Effectiveness Check Form prior to the return of all unused products to Abbott Vascular.

Device

NC Trek Rx Coronary Dilatation System

Manufacturer

Abbott Vascular Division of Abbott Australasia Pty Ltd
  • 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
    DHTGA