Events

Recall of Threader Monorail and Threader Over the Wire Micro-Dilatation Catheters (used during angioplasty procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific 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-2016-RN-00612-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00612-1
  • 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
    Boston scientific has determined that certain threader monorail and threader over the wire micro-dilatation catheters were shipped from the australia distribution centre with an international direction for use (dfu) rather than an australian dfu. the australian dfu includes additional warnings and precautions included in the ‘precaution’ section of the dfu.
  • Action
    Boston Scientific is providing users with the Australian DFU. This action has been closed-out on 17/02/2017.

Device

Threader Monorail and Threader Over the Wire Micro-Dilatation Catheters (used during angioplasty ...
  • Model / Serial
    Threader Monorail and Threader Over the Wire Micro-Dilatation Catheters (used during angioplasty procedures)Threader Monorail Micro-Dilatation CatheterMaterial Number (UPN): H7493926912120Batch Number:18647602Threader Over the Wire Micro-Dilatation CatheterMaterial Number (UPN): H7493927012120Batch Numbers: 18647652, 18753516, 18647655 ARTG Numbers: 259153, 259152
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA