Events

Recall of 4.0mm x15mm Small Peripheral Cutting Balloon (Monorail & Over-the-Wire ) Microsurgical Dilatation Device (used for Percutaneous Transluminal Angioplasty of obstructive lesions in peripheral vessels) and 4.00mm x15mm Flextome Cutting Balloon (Monorail & Over-the-Wire) Microsurgical Dilatation Device (used in patients with coronary vessel disease)

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-2013-RN-00848-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00848-1
  • 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 users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device.
  • Action
    Customers are asked to segregate the affected product immediately from their inventory and return it to Boston Scientific.

Device

4.0mm x15mm Small Peripheral Cutting Balloon (Monorail & Over-the-Wire ) Microsurgical Dilatation...
  • Model / Serial
    4.0mm x15mm Small Peripheral Cutting Balloon (Monorail & Over-the-Wire ) Microsurgical Dilatation Device (used for Percutaneous Transluminal Angioplasty of obstructive lesions in peripheral vessels) and 4.00mm x15mm Flextome Cutting Balloon (Monorail & Over-the-Wire) Microsurgical Dilatation Device (used in patients with coronary vessel disease) Multiple catalogue numbers and lot numbers Expiration Date Range: 16-Nov-2015 to 03-Jun-2016ARTG Numbers: 168036 and 169861
  • 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