Events

Recall of Given Imaging Bravo pH monitoring systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien 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-00477-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00477-1
  • 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
    Medtronic has received three customer complaints related to patients having allergic reactions to the nickel content in the stainless steel trocar needle that attaches the bravo capsule to the oesophageal mucosa. allergic reactions can include hives, itching or oral numbness.
  • Action
    Medtronic is providing customers with updated user manuals and product package inserts which include information in relation to the metal content of the device and precautions regarding metal allergies. This action has been closed-out on 27/01/2017.

Device

Given Imaging Bravo pH monitoring systems
  • Model / Serial
    Given Imaging Bravo pH monitoring systemsBravo pH capsule delivery device, 5-packItem Code: FGS-0312Bravo pH capsule delivery device, 1-packItem Code: FGS-0313ARTG Number: 205795
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA